510(k) K890990 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE
| Applicant | Hichem Diagnostics, Brea CA, US |
| Decision | Substantially Equivalent, Apr 10, 1989 |
| Received | Feb 27, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K890990
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.