B. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and Prevention
B. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and Prevention (Georgia): 510(k) cleared for Centers for Disease Control and Prevention. Its amount of 89 is below the median of 138 (29th percentile). Dated 29 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: 89 · 29th percentile of 414 FDAPulse records · 0.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 68 related GA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262368 |
| Device | B. anthracis Real-time PCR Assay |
| Applicant | Centers for Disease Control and Prevention |
| Specialty / panel | Microbiology |
| Product code | NHT |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-10 |
| Decision date | 2026-10-07 |
| Review time (days) | 89 |
| Third-party review | No |
| Applicant location | Atlanta, GA, US |
| amount percentile | 29th of 414 (median 138, 0.6x median) |
| Peer records CSV (69 GA records) | 🔒 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: 2026-10-07
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (GA first): OAB Delivery Catheter (K253422) · DynaNail Helix® Fixation System (K260995) · CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test · CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel · Class II recall Z-0004-2027 · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 21:30:53 GMT
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Peer benchmark and outreach value: B. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and Prevention and 69 Georgia peers
- Georgia FDAPulse records like this one: 69
- B. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and Prevention's amount: 29th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Georgia peer: $13,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 89-day review: this device is a strong predicate for similar products.
- Posted 29 days ago.
What is the FDAPulse record for B. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and Prevention in Georgia?
B. anthracis Real-time PCR Assay (K262368) by Centers for Disease Control and Prevention was cleared on 2026-10-07 after 89 days of review.
How does B. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and Prevention compare to other Georgia FDAPulse records?
Its amount of 89 is below the median (29th percentile); smaller records often move faster and face less competition. It is 29 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.
B. anthracis Real-time PCR Assay (K262368) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| B. anthracis Real-time PCR Assay (K262368) | GA | 2026-10-07 |
| 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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