510(k) K921616 ยท LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
CMV-VUE(TM) CMV ANTIGEN DETECTION KIT
| Applicant | Incstar Corp., Stillwater MN, US |
| Decision | Substantially Equivalent for Some Indications, Aug 11, 1992 |
| Received | Apr 6, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921616
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.