510(k) K951632 ยท GKZ Counter, Differential Cell
ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Mar 6, 1997 |
| Received | Apr 7, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951632
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.