Ark Diagnostics Inc (manufacturer, Fremont, CA): 2 new FDA device listings, incl. anti-factor xa activity test system, apixaban
Ark Diagnostics Inc (Fremont, California): 2 new FDA device listings, incl. anti-factor xa activity test system, apixaban. Its amount of 2 is above the median of 1 (69th percentile). Dated 54 days ago, it serves as a historical benchmark. Score 70/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 2 · 69th percentile of 2,570 DeviceEstablishmentPulse records · 2.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 283 related CA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Ark Diagnostics Inc |
| Owner / operator | ARK Diagnostics Inc |
| Role | Manufacturer |
| Establishment types | Manufacture Device in the United States for Export Only |
| Location | Fremont, CA, US |
| New listings | 2 |
| Devices | Anti-Factor Xa Activity Test System, Apixaban; Enzyme Immunoassay, Benzodiazepine |
| Product codes | QLU, JXM |
| Device classes | Class II |
| Medical specialties | Hematology, Clinical Toxicology |
| Brand names | ARK Apixaban Control; ARK Apixaban Calibrator; ARK Apixaban Assay; ARK Zopiclone Assay; ARK Zopiclone Control; ARK Zopiclone Calibrator |
| First new listing | 2026-09-01 |
| Latest new listing | 2026-09-11 |
| FDA registration number | 3005755244 |
| Registration expires | 2027-12-31 |
| amount percentile | 69th of 2,570 (median 1, 2.0x median) |
| Peer records CSV (284 CA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-09-11
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Ark Diagnostics Inc and 284 California peers
- California DeviceEstablishmentPulse records like this one: 284
- Ark Diagnostics Inc's amount: 69th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $56,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
70 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Ark Diagnostics Inc in Fremont, California?
Ark Diagnostics Inc (Fremont, CA), a manufacturer, added 2 FDA device listings between 2026-09-01 and 2026-09-11.
How does Ark Diagnostics Inc compare to other California DeviceEstablishmentPulse records?
Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 54 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.
Ark Diagnostics Inc vs. top 2 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Ark Diagnostics Inc | Fremont, CA | 2 | 69th | 2026-09-11 |
| Endovascular Engineering, Inc. | Menlo Park, CA | 3 | 77th | 2026-10-14 |
| Inquis Medical, Inc. | Menlo Park, CA | 5 | 87th | 2026-10-16 |
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.