510(k) K905658 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
SYSTEMATE CREATININE (EPOS APPLICATION) #65413
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, May 8, 1991 |
| Received | Dec 18, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905658
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.