SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573): 510(k) cleared for Maine Molecular Quality Controls, Inc.
SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573): 510(k) cleared for Maine Molecular Quality Controls, Inc. (Maine): 510(k) cleared for Maine Molecular Quality Controls, Inc. Its amount of 86 is below the median of 138 (26th percentile). Dated 15 days ago, it is in the active follow-up window. Score 36/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 86 · 26th percentile of 414 FDAPulse records · 0.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 1 related ME FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262573 |
| Device | SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control |
| Applicant | Maine Molecular Quality Controls, Inc. |
| Specialty / panel | Microbiology |
| Product code | PMN |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-27 |
| Decision date | 2026-10-21 |
| Review time (days) | 86 |
| Third-party review | No |
| Applicant location | Saco, ME, US |
| amount percentile | 26th of 414 (median 138, 0.6x median) |
| Peer records CSV (2 ME records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-21
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573): 510(k) cleared for Maine Molecular Quality Controls, Inc. and 2 Maine peers
- Maine FDAPulse records like this one: 2
- SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573): 510(k) cleared for Maine Molecular Quality Controls, Inc.'s amount: 26th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Maine peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 86-day review: this device is a strong predicate for similar products.
- Posted 15 days ago.
What is the FDAPulse record for SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573): 510(k) cleared for Maine Molecular Quality Controls, Inc. in Maine?
SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573) by Maine Molecular Quality Controls, Inc. was cleared on 2026-10-21 after 86 days of review.
How does SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573): 510(k) cleared for Maine Molecular Quality Controls, Inc. compare to other Maine FDAPulse records?
Its amount of 86 is below the median (26th percentile); smaller records often move faster and face less competition. It is 15 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573) | ME | 2026-10-21 |
| B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302) | DE | 2026-10-23 |
| Elecsys EBV EBNA IgG (K260221) | IN | 2026-10-02 |
| Elecsys EBV VCA IgG (K260232) | IN | 2026-10-02 |
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