510(k) K983345 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 7, 1998 |
| Received | Sep 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983345
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.