510(k) K971506 ยท DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jun 3, 1997 |
| Received | Apr 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971506
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.