510(k) K964452 ยท GLK Control, Hematocrit
HEMATACHEK
| Applicant | Richmond Diagnostics, Inc., New Brunswick NJ, US |
| Decision | Substantially Equivalent, Feb 20, 1997 |
| Received | Nov 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964452
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.