510(k) K883836 ยท GGK Products, Red-Cell Lysing Products
COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II
| Applicant | Coulter Immunology, Hialeah FL, US |
| Decision | Substantially Equivalent, Nov 30, 1988 |
| Received | Sep 12, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883836
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.