Cleared Traditional

PICCOLO HDL-CAPILLARY TEST SYSTEM

K120662 · Abaxis, Inc. · Chemistry
Apr 2012
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K120662 is an FDA 510(k) clearance for the PICCOLO HDL-CAPILLARY TEST SYSTEM, a Colorimetric Method, Lipoproteins (Class I — General Controls, product code JHM), submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on April 24, 2012, 50 days after receiving the submission on March 5, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K120662 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2012
Decision Date April 24, 2012
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHM — Colorimetric Method, Lipoproteins
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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