510(k) K982311 ยท GQH Antigen, Cf (Including Cf Control), Cytomegalovirus
BARTELS CINAKIT CMV ANTIGENEMIA
| Applicant | Intracel Corp., Rockville MD, US |
| Decision | Substantially Equivalent, Dec 14, 1998 |
| Received | Jul 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982311
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.