510(k) K912806 ยท KHS Enzymatic, Carbon-Dioxide
ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Sep 11, 1991 |
| Received | Jun 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912806
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.