510(k) K853304 ยท GKZ Counter, Differential Cell
21 HEMATOLOGY REAGENTS
| Applicant | In Vitro Diagnostics, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Nov 12, 1985 |
| Received | Aug 5, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853304
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.