510(k) K001397 ยท DKZ Enzyme Immunoassay, Amphetamine
QUICKSCREEN PRO DRUG CUP, MODEL 9195X
| Applicant | Phamatech, San Diego CA, US |
| Decision | Substantially Equivalent, May 26, 2000 |
| Received | May 3, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001397
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.