K946268 is an FDA 510(k) clearance for the BACTEC(R) 9000TB SYSTEM. This device is classified as a System, Blood Culturing (Class I - General Controls, product code MDB).
Submitted by Becton Dickinson Diagnostic Instrument Systems (Sparks, US). The FDA issued a Cleared decision on May 21, 1996, 515 days after receiving the submission on December 23, 1994.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2560.
| 510(k) Number | K946268 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1994 |
| Decision Date | May 21, 1996 |
| Days to Decision | 515 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MDB — System, Blood Culturing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2560 |