510(k) K912826 ยท DKC Alcohol Control Materials
WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2
| Applicant | Cala Diagnostics, Los Osos CA, US |
| Decision | Substantially Equivalent, Jul 26, 1991 |
| Received | Jun 26, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912826
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.