510(k) K060645 ยท DKB Calibrators, Drug Mixture
PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 30, 2006 |
| Received | Mar 10, 2006 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K060645
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.