510(k) K973369 ยท LBR Ldl & Vldl Precipitation, Hdl
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Nov 21, 1997 |
| Received | Sep 8, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973369
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.