510(k) K181553 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Immunalysis Ethyl Alcohol Enzyme Assay
| Applicant | Immunalysis Corporation, Pomona CA, US |
| Decision | Substantially Equivalent, Oct 31, 2018 |
| Received | Jun 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181553
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.