510(k) K050652 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
SPOTCHEM II CREATININE, AMYLASE & ALP TESTS
| Applicant | Arkray, Inc., Cortlandt Manor NY, US |
| Decision | Substantially Equivalent, Apr 6, 2005 |
| Received | Mar 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050652
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.