510(k) K991650 ยท LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
CMV BRITE TURBO KIT
| Applicant | Biotest Diagnostics Corp., Denville NJ, US |
| Decision | Substantially Equivalent, Jul 12, 1999 |
| Received | May 13, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K991650
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.