510(k) K012291 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Aug 20, 2001 |
| Received | Jul 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012291
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.