510(k) K935550 ยท DKB Calibrators, Drug Mixture
ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Jan 3, 1994 |
| Received | Nov 17, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935550
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.