510(k) K001032 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY
| Applicant | Otsuka Pharmaceutical Co., Ltd., Rockville MD, US |
| Decision | Substantially Equivalent, Jul 24, 2000 |
| Received | Mar 30, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001032
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.