510(k) K973284 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
COBAS INTEGRA HDL-CHOLESTEROL DIRECT
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Dec 18, 1997 |
| Received | Sep 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973284
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.