510(k) K897147 ยท KHP Acid, Lactic, Enzymatic Method
SIGMA PROCEDURE NO. 735
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Apr 3, 1990 |
| Received | Dec 26, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897147
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.