510(k) K203527 ยท DJG Enzyme Immunoassay, Opiates
Immunalysis Tapentadol Urine HEIA
| Applicant | Lmmunalysis Corporation, Pomona CA, US |
| Decision | Substantially Equivalent, May 9, 2022 |
| Received | Dec 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203527
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.