510(k) K950164 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR
| Applicant | Abaxis, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Apr 13, 1995 |
| Received | Jan 17, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950164
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2011 | Abaxis, Incorporated Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer; Catalog/Part Number: 400-0028;
Product is manufactured and dis Terminated |
CKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.