Cleared Traditional

QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT

K990654 · Quantase , Ltd. · Chemistry
Jun 1999
Decision
112d
Days
Class 1
Risk

About This 510(k) Submission

K990654 is an FDA 510(k) clearance for the QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT, a Enzymatic Methods, Galactose (Class I — General Controls, product code JIA), submitted by Quantase , Ltd. (Perth, Scotland, GB). The FDA issued a Cleared decision on June 21, 1999, 112 days after receiving the submission on March 1, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1310.

Submission Details

510(k) Number K990654 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 1999
Decision Date June 21, 1999
Days to Decision 112 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIA — Enzymatic Methods, Galactose
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1310

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