510(k) K911834 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
OPUS(R) ROZO
| Applicant | Pb Diagnostic Systems, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Aug 12, 1991 |
| Received | Apr 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911834
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.