510(k) K895022 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
SYSTEMATE CREATININE TEST (CREA) #65413
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Oct 23, 1989 |
| Received | Aug 8, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895022
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.