K003062 is an FDA 510(k) clearance for the BACTEC MGIT 960 SIR KITS. This device is classified as a Susceptibility Test Powders, Antimycobacterial (Class II - Special Controls, product code MJA).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sparks, US). The FDA issued a Cleared decision on June 6, 2001, 247 days after receiving the submission on October 2, 2000.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K003062 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2000 |
| Decision Date | June 06, 2001 |
| Days to Decision | 247 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MJA — Susceptibility Test Powders, Antimycobacterial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |