K801693 is an FDA 510(k) clearance for the SALMONELLA FLAGELLAR A ANTIGEN & B. This device is classified as a Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. (Class II - Special Controls, product code GNC).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on August 27, 1980, 35 days after receiving the submission on July 23, 1980.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3550.
| 510(k) Number | K801693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 1980 |
| Decision Date | August 27, 1980 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GNC — Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3550 |