K962609 is an FDA 510(k) clearance for the GRAM NEGATIVE IDENTIFICATION PLUS CARD. This device is classified as a Instrument For Auto Reader Of Overnight Microorganism Identification System (Class I - General Controls, product code LRH).
Submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on August 30, 1996, 58 days after receiving the submission on July 3, 1996.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K962609 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 1996 |
| Decision Date | August 30, 1996 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LRH — Instrument For Auto Reader Of Overnight Microorganism Identification System |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |