510(k) K112422 ยท GMD Antisera, Latex Agglutination, Cryptococcus Neoformans
CRAG LATERAL FLOW ASSAY (LFA)
| Applicant | Immuno-Mycologics, Inc., Norman OK, US |
| Decision | Substantially Equivalent, Mar 28, 2012 |
| Received | Aug 23, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112422
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2022 | Immuno-Mycologics, Inc CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919 Terminated |
GMD | None listed |
| Mar 30, 2018 | Immuno-Mycologics, Inc Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003
Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detectio Terminated |
GMD | None listed |
| Jan 27, 2017 | Immuno-Mycologics, Inc Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003 Terminated |
GMD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.