510(k) K955627 ยท LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
VIDAS CHLAMYDIA BLOCKING ASSAY
| Applicant | Biomerieux Vitek, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Oct 7, 1996 |
| Received | Dec 11, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955627
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.