Panels › Immunology › Product code SGA · Class 2
Biothreat Microbial Agent Nucleic Acid Detection Test
Regulation 866.4000
1510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SGA
| Company | 510(k)s | Recalls |
|---|---|---|
| Centers for Disease Control and Prevention | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 30, 2026 | K260812 | Francisella tularensis Real-time PCR Assay Centers for Disease Control and Prevention | SGA |
| Sep 30, 2025 | K252072 | Francisella tularensis Real-time PCR assay Centers for Disease Control and Prevention | SGA |
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