510(k) K923166 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
VIDAS TOXOPLASMA GONDII IGM ASSSAY
| Applicant | Biomerieux Vitek, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Feb 25, 1993 |
| Received | Jun 29, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923166
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.