510(k) K061775 ยท JFY Enzymatic Method, Creatinine
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
| Applicant | Wako Chemicals USA, Inc., Richmond VA, US |
| Decision | Substantially Equivalent, Feb 23, 2007 |
| Received | Jun 23, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061775
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.