510(k) K921998 ยท DKZ Enzyme Immunoassay, Amphetamine
ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, May 26, 1992 |
| Received | Apr 23, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921998
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.