510(k) K904524 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
CAPTIA(R) SYPHILIS M, MODIFICATION
| Applicant | Mercia Diagnostics , Ltd., Guildford, Surrey England, GB |
| Decision | Substantially Equivalent, Dec 26, 1990 |
| Received | Sep 27, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904524
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for th Terminated |
LIP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.