510(k) K991907 ยท CZW Complement C3, Antigen, Antiserum, Control
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Nov 9, 1999 |
| Received | Jun 7, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991907
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.