Cleared Traditional

DYE CHECK STRIPS 545-630

K943729 · Awareness Technology, Inc. · Chemistry
Dec 1994
Decision
149d
Days
Class 1
Risk

About This 510(k) Submission

K943729 is an FDA 510(k) clearance for the DYE CHECK STRIPS 545-630, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Awareness Technology, Inc. (Palm City, US). The FDA issued a Cleared decision on December 29, 1994, 149 days after receiving the submission on August 2, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K943729 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 1994
Decision Date December 29, 1994
Days to Decision 149 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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