510(k) K941713 ยท GKZ Counter, Differential Cell
ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE)
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Apr 26, 1995 |
| Received | Mar 3, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941713
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.