510(k) K915884 ยท LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
VIDAS CHLAMYDIA ASSAY, MODIFICATION
| Applicant | Vitek Systems, Inc., Hazelwood MI, US |
| Decision | Substantially Equivalent, Mar 4, 1992 |
| Received | Dec 12, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915884
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2003 | bioMerieux VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use
Product Number: 30101 Terminated |
LJC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.