510(k) K905787 ยท LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST
| Applicant | Vitek Systems, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Apr 29, 1991 |
| Received | Dec 27, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905787
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2011 | bioMerieux, Inc. VIDAS Chlamydia test kits
VIDAS Chlamydia is an automated qualitative test for use on the VIDAS family instruments, for the detection of Chlamydia antigen in endocervical or urethral specimens, using Terminated |
LJC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.