510(k) K904031 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
CHEMA CHOL CHOLESTEROL SYSTEM
| Applicant | Texas Intl. Laboratories, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Mar 11, 1991 |
| Received | Aug 31, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904031
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.