Cleared Traditional

PICCOLO(TM)

K942782 · Abaxis, Inc. · Chemistry
Mar 1995
Decision
273d
Days
Class 1
Risk

About This 510(k) Submission

K942782 is an FDA 510(k) clearance for the PICCOLO(TM), a Analyzer, Chemistry, Centrifugal, For Clinical Use (Class I — General Controls, product code JJG), submitted by Abaxis, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 13, 1995, 273 days after receiving the submission on June 13, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2140.

Submission Details

510(k) Number K942782 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 1994
Decision Date March 13, 1995
Days to Decision 273 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJG — Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2140

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