Cleared Traditional

PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM

K130200 · Abaxis, Inc. · Chemistry
Feb 2013
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K130200 is an FDA 510(k) clearance for the PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on February 15, 2013, 18 days after receiving the submission on January 28, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K130200 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2013
Decision Date February 15, 2013
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

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