510(k) K863738 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Nov 5, 1986 |
| Received | Sep 23, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863738
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.