K900996 is an FDA 510(k) clearance for the VITEK ANAEROBE IDENTIFICATION CARD. This device is classified as a Kit, Anaerobic Identification (Class I - General Controls, product code JSP).
Submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on May 11, 1990, 70 days after receiving the submission on March 2, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K900996 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 1990 |
| Decision Date | May 11, 1990 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSP — Kit, Anaerobic Identification |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |