510(k) K801296 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
COBAS REAGENT FOR CHOLESTEROL
| Applicant | Roche Analytical Instruments, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 30, 1980 |
| Received | Jun 2, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801296
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.