PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM— 510(k) K120664

Name: FDA 510(k) clearance K120664
Creator: U.S. Food and Drug Administration
Published: 2012-04-24

Substantially Equivalent

Abaxis, Inc.

FDA 510(k) clearance K120664 for PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM, Substantially Equivalent on 2012-04-24. Applicant: Abaxis, Inc.. Device class: 1.

Clearance details

Applicant: Abaxis, Inc.
Product code: Code JGY
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 2012-03-05
Decision date: 2012-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Union City, CA, US

Download summary PDF View on FDA.gov ↗

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