510(k) K890027 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD
| Applicant | Photec Diagnostics, Inc., Little Falls NJ, US |
| Decision | Substantially Equivalent, Apr 26, 1989 |
| Received | Jan 4, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K890027
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.