510(k) K021428 ยท JFY Enzymatic Method, Creatinine
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jul 5, 2002 |
| Received | May 3, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021428
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.