PICCOLO TOTAL CHOLESTEROL TEST SYSTEM— 510(k) K023642

Name: FDA 510(k) clearance K023642
Creator: U.S. Food and Drug Administration
Published: 2003-01-24

Substantially Equivalent

Abaxis, Inc.

FDA 510(k) clearance K023642 for PICCOLO TOTAL CHOLESTEROL TEST SYSTEM, Substantially Equivalent on 2003-01-24. Applicant: Abaxis, Inc.. Device class: 1.

Clearance details

Applicant: Abaxis, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 2002-10-30
Decision date: 2003-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Union City, CA, US

Download summary PDF View on FDA.gov ↗

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