Francisella tularensis Real-time PCR assay
FDA 510(k) clearance K252072 · decided 2025-09-30
Clearance details
- K-number
- K252072
- Device name
- Francisella tularensis Real-time PCR assay
- Applicant
- Centers for Disease Control and Prevention
- Decision
- Substantially Equivalent
- Date received
- 2025-07-01
- Decision date
- 2025-09-30
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- SGA
- Device class
- 2
- Regulation number
- 866.4000
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Francisella tularensis Real-time PCR Assay (K260812) | Centers for Disease Control and Prevention | 2026-03-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AFP MID-PREGNANCY REFERENCE PREPARATION (P820077) | Centers for Disease Control and Prevention | 1984-11-30 |