510(k) K073489 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
OLYMPUS IGA REAGENT
| Applicant | Olympus America, Inc., Co. Clare, IE |
| Decision | Substantially Equivalent, Feb 11, 2008 |
| Received | Dec 12, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073489
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2023 | Beckman Coulter Inc. Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2 Open, Classified |
CFN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.