510(k) K023889 ยท MIU Enzyme Linked Immunosorbent Assay, T. Cruzi
WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
| Applicant | Wiener Laboratories Saic, Rosario, Santa Fe, AR |
| Decision | Substantially Equivalent, Feb 11, 2004 |
| Received | Nov 21, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023889
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2017 | Wiener Laboratories Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0
Diagnosis of Chagas disease. Open, Classified |
MIU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.