K895362 is an FDA 510(k) clearance for the BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST. This device is classified as a Susceptibility Test Powders, Antimicrobial (Class II - Special Controls, product code JTT).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on December 1, 1989, 94 days after receiving the submission on August 29, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K895362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1989 |
| Decision Date | December 01, 1989 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTT — Susceptibility Test Powders, Antimicrobial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |