Cleared Traditional

REDI-CHECK PHOTMETER Q.A.

K923598 · Awareness Technology, Inc. · Chemistry
Oct 1992
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K923598 is an FDA 510(k) clearance for the REDI-CHECK PHOTMETER Q.A., a Coulometric, Chloride (Class II — Special Controls, product code JFS), submitted by Awareness Technology, Inc. (Palm City, US). The FDA issued a Cleared decision on October 14, 1992, 86 days after receiving the submission on July 20, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K923598 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1992
Decision Date October 14, 1992
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JFS — Coulometric, Chloride
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1170

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