510(k) K894509 ยท KHS Enzymatic, Carbon-Dioxide
BICARBONATE TEST ITEM NUMBER: 65412
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Sep 15, 1989 |
| Received | Jul 19, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894509
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.