Oncomine Dx Express Test (K260827): 510(k) cleared for Life Technologies Corporation
Oncomine Dx Express Test (K260827): 510(k) cleared for Life Technologies Corporation (Maryland): 510(k) cleared for Life Technologies Corporation. Its amount of 216 is above the median of 138 (70th percentile). Dated 20 days ago, it is in the active follow-up window. Score 48/100. As of 2026-11-03, 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: 216 · 70th percentile of 414 FDAPulse records · 1.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 4 related MD FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260827 |
| Device | Oncomine Dx Express Test |
| Applicant | Life Technologies Corporation |
| Specialty / panel | Other |
| Product code | SBY |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-03-13 |
| Decision date | 2026-10-15 |
| Review time (days) | 216 |
| Third-party review | No |
| Applicant location | Frederick, MD, US |
| amount percentile | 70th of 414 (median 138, 1.6x median) |
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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: 2026-10-15
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (MD first): BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco M · CraniUS Plate (K262874) · Class II recall Z-0139-2027 · Class II recall Z-0140-2027 · SmartIPL_NI System (K241973) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Oncomine Dx Express Test (K260827): 510(k) cleared for Life Technologies Corporation and 5 Maryland peers
- Maryland FDAPulse records like this one: 5
- Oncomine Dx Express Test (K260827): 510(k) cleared for Life Technologies Corporation's amount: 70th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Maryland peer: $1,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 216-day review, longer than typical.
- Posted 20 days ago.
What is the FDAPulse record for Oncomine Dx Express Test (K260827): 510(k) cleared for Life Technologies Corporation in Maryland?
Oncomine Dx Express Test (K260827) by Life Technologies Corporation was cleared on 2026-10-15 after 216 days of review.
How does Oncomine Dx Express Test (K260827): 510(k) cleared for Life Technologies Corporation compare to other Maryland FDAPulse records?
Its amount of 216 sits in the upper half (70th percentile) of 414 records; the median is 138. It is 20 days old, still within a typical 45-day follow-up window.
Oncomine Dx Express Test (K260827) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Oncomine Dx Express Test (K260827) | MD | 2026-10-15 |
| Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230) | CN | 2026-10-22 |
| STA® - Liquid Anti-Xa (K260214) | NJ | 2026-09-24 |
| BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215) | CA | 2026-10-20 |
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- BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215): 510(k) cleared for Bd Biosciences
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