Cleared Traditional

GDS ENZYMATIC SALICYLATE REAGENT

K882038 · Gds Technology, LLC · Chemistry
Jun 1988
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K882038 is an FDA 510(k) clearance for the GDS ENZYMATIC SALICYLATE REAGENT, a Colorimetry, Salicylate (Class II — Special Controls, product code DKJ), submitted by Gds Technology, LLC (Elkhart, US). The FDA issued a Cleared decision on June 24, 1988, 39 days after receiving the submission on May 16, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3830.

Submission Details

510(k) Number K882038 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 1988
Decision Date June 24, 1988
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code DKJ — Colorimetry, Salicylate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3830

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