510(k) K082823 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS
| Applicant | The Binding Site Group , Ltd., Los Angeles CA, US |
| Decision | Substantially Equivalent, Mar 1, 2010 |
| Received | Sep 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082823
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.