K822946 is an FDA 510(k) clearance for the BACTEC NAP TB DIFFERENTIATION TEST. This device is classified as a Discs, Strips And Reagents, Microorganism Differentiation (Class I - General Controls, product code JTO).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on November 12, 1982, 39 days after receiving the submission on October 4, 1982.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K822946 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1982 |
| Decision Date | November 12, 1982 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTO — Discs, Strips And Reagents, Microorganism Differentiation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |