510(k) K140455 ยท PCL Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
CAPTIA MEASLES IGM
| Applicant | Trinity Biotech USA, Jamestown NY, US |
| Decision | Substantially Equivalent, May 22, 2014 |
| Received | Feb 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140455
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2021 | Clark Laboratories, Inc. Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) Terminated |
PCL | None listed |
| Sep 12, 2016 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD Terminated |
PCL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.