510(k) K203647 ยท LAF Gas Chromatography, Methamphetamine
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
| Applicant | Immunalysis Corporation, Pomona CA, US |
| Decision | Substantially Equivalent, Dec 22, 2021 |
| Received | Dec 14, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203647
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.