510(k) K033860 ยท JIT Calibrator, Secondary
AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
| Applicant | Wako Chemicals USA, Inc., Richmond VA, US |
| Decision | Substantially Equivalent, Apr 23, 2004 |
| Received | Dec 12, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033860
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.