K952095 is an FDA 510(k) clearance for the VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI). This device is classified as a Gram Positive Identification Panel (Class I - General Controls, product code LQL).
Submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on March 12, 1996, 313 days after receiving the submission on May 4, 1995.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K952095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1995 |
| Decision Date | March 12, 1996 |
| Days to Decision | 313 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LQL — Gram Positive Identification Panel |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |