510(k) K894288 ยท CED 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
PHOSPHORUS TEST ITEM NUMBER 65416
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Aug 31, 1989 |
| Received | Jun 23, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894288
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.