510(k) K993213 ยท CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
K-ASSAY IGA
| Applicant | Kamiya Biomedical Co., Seattle WA, US |
| Decision | Substantially Equivalent, Nov 23, 1999 |
| Received | Sep 24, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993213
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2022 | Kamiya Biomedical Company, LLC K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013 Open, Classified |
CFF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.