510(k) K972891 ยท DKZ Enzyme Immunoassay, Amphetamine
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Oct 1, 1997 |
| Received | Aug 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972891
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.