510(k) K921523 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
OPUS(R) TOXO-G TEST SYSTEM
| Applicant | Pb Diagnostics, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Sep 14, 1992 |
| Received | Mar 31, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921523
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.