510(k) K963539 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
SIGMA DIAGNOSTICS WASH CONCENTRATE
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Dec 16, 1996 |
| Received | Sep 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963539
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.