510(k) K974779 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER
| Applicant | Abbott Laboratories, Irving TX, US |
| Decision | Substantially Equivalent, Feb 13, 1998 |
| Received | Dec 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974779
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.