510(k) K853391 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000
| Applicant | Eiken Chemical Co., Inc., Venice CA, US |
| Decision | Substantially Equivalent, Oct 1, 1985 |
| Received | Aug 13, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853391
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.