Cleared Traditional

EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR

K934592 · Abaxis, Inc. · Chemistry
Apr 1994
Decision
194d
Days
Class 1
Risk

About This 510(k) Submission

K934592 is an FDA 510(k) clearance for the EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR, 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 April 6, 1994, 194 days after receiving the submission on September 24, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2140.

Submission Details

510(k) Number K934592 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 1993
Decision Date April 06, 1994
Days to Decision 194 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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