510(k) K881932 ยท GQH Antigen, Cf (Including Cf Control), Cytomegalovirus
ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Aug 1, 1988 |
| Received | May 10, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881932
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.