Cleared Traditional

SODIUM REAGENT SET

K902572 · Tech Intl. Co. · Chemistry

Jul 1990

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K902572 is an FDA 510(k) clearance for the SODIUM REAGENT SET, a Uranyl Acetate/zinc Acetate, Sodium (Class II — Special Controls, product code CEI), submitted by Tech Intl. Co. (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 862.1665.

Submission Details

510(k) Number	K902572 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	—