510(k) K923579 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
MINIVIDAS INSTRUMENT
| Applicant | Biomerieux Vitek, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Feb 12, 1993 |
| Received | Jul 20, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923579
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2018 | bioMerieux, Inc. BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*)
Product Usage:
the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS system to detect abnormal opera Terminated |
JJE | None listed |
| May 9, 2018 | bioMerieux, Inc. BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*)
Product Usage:
the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS system to detect abnormal operation Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.