K902609 is an FDA 510(k) clearance for the DIRECTIGEN FLU A. This device is classified as a Antigens, Ha (including Ha Control), Influenza Virus A, B, C (Class I - General Controls, product code GNT).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on September 10, 1990, 90 days after receiving the submission on June 12, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3330.
| 510(k) Number | K902609 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 1990 |
| Decision Date | September 10, 1990 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GNT — Antigens, Ha (including Ha Control), Influenza Virus A, B, C |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3330 |