Cleared Traditional

PICCOLO CHLORIDE TEST SYSTEM

K010670 · Abaxis, Inc. · Chemistry
Apr 2001
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K010670 is an FDA 510(k) clearance for the PICCOLO CHLORIDE TEST SYSTEM, a Mercuric Thiocyanate, Colorimetry, Chloride (Class II — Special Controls, product code CHJ), submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on April 26, 2001, 51 days after receiving the submission on March 6, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K010670 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2001
Decision Date April 26, 2001
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHJ — Mercuric Thiocyanate, Colorimetry, Chloride
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1170

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