510(k) K000410 ยท DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Apr 10, 2000 |
| Received | Feb 8, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000410
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.