510(k) K992132 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
CHOLESITE TEST SYSTEM
| Applicant | Gds Technology, LLC, Elkhart IN, US |
| Decision | Substantially Equivalent, Aug 20, 1999 |
| Received | Jun 23, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992132
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.