K812808 is an FDA 510(k) clearance for the BBL DIRECTIGEN TEST KIT. This device is classified as a Antigens, All Groups, Streptococcus Spp. (Class I - General Controls, product code GTY).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 30, 1981, 85 days after receiving the submission on October 6, 1981.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K812808 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 1981 |
| Decision Date | December 30, 1981 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GTY — Antigens, All Groups, Streptococcus Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |