510(k) K260812
- Device
- Francisella tularensis Real-time PCR Assay
- Applicant
- Centers for Disease Control and Prevention
- 510(k) number
- K260812
- Product code
- SGA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-30
- Date received
- 2026-03-13
- Regulation
- 866.4000
- Classification name
- Biothreat Microbial Agent Nucleic Acid Detection Test
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Jasmine Chaitram
- Address
- 1600 Clifton Rd., NE Ms H24-2 Atlanta GA US 30329 30329
FDA Registration Numbers
- 1050190
Source Documents
Other 510(k) Records For Product Code SGA
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252072 | Francisella tularensis Real-time PCR assay | Centers for Disease Control and Prevention | 2025-09-30 |