Cleared Traditional

SODIUM REAGENT SET

K914039 · Sterling Diagnostics, Inc. · Chemistry

Oct 1991

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K914039 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 Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on October 31, 1991, 51 days after receiving the submission on September 10, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number	K914039 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 1991
Decision Date	October 31, 1991
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement