Cleared Traditional

POTASSIUM REAGENT SET

K902574 · Tech-Co, Inc. · Chemistry
Jul 1990
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K902574 is an FDA 510(k) clearance for the POTASSIUM REAGENT SET, a Tetraphenyl Borate, Colorimetry, Potassium (Class II — Special Controls, product code CEJ), submitted by Tech-Co, Inc. (Rochester Hills, US). The FDA issued a Cleared decision on July 10, 1990, 29 days after receiving the submission on June 11, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K902574 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 1990
Decision Date July 10, 1990
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CEJ — Tetraphenyl Borate, Colorimetry, Potassium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1600

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