510(k) K952095 ยท LQL Gram Positive Identification Panel
VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)
| Applicant | Biomerieux Vitek, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Mar 12, 1996 |
| Received | May 4, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952095
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2017 | Biomerieux Inc VITEK2 GP-ID, REF 21342 IVD Terminated |
LQL | None listed |
| Aug 25, 2017 | Biomerieux Inc VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc.
VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimic Terminated |
LQL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.