510(k) K905828 ยท DKB Calibrators, Drug Mixture
ABUSCREEN(R) ONLINE CALIBRATORS
| Applicant | Roche Diagnostic Systems, Inc., Montclair NJ, US |
| Decision | Substantially Equivalent, Feb 4, 1991 |
| Received | Dec 18, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905828
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.