510(k) K982848 ยท MRR System, Test, Low Density, Lipoprotein
COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Oct 1, 1998 |
| Received | Aug 12, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982848
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.