510(k) K981912 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
HUMAN IGA SUBCLASS BNII COMBI KIT
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Dec 4, 1998 |
| Received | Jun 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981912
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.