510(k) K905257 ยท LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
OPUS CMV TEST SYSTEM
| Applicant | Pb Diagnostic Systems, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Apr 17, 1991 |
| Received | Nov 21, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905257
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.