510(k) K890305 ยท KHS Enzymatic, Carbon-Dioxide
BICARBONATE TEST ITEM NUMBER: SR1006
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Feb 17, 1989 |
| Received | Jan 23, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K890305
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.