510(k) K933549 ยท LKQ Antibody Igm,If, Cytomegalovirus Virus
VIDAS CMV IGM ASSAY
| Applicant | Biomerieux Vitek, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Aug 2, 1994 |
| Received | Jul 22, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K933549
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2022 | bioMerieux, Inc. VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. Terminated |
LKQ | None listed |
| Mar 16, 2021 | Biomerieux Inc VIDAS CMV IgM 30 Tests Terminated |
LKQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.