Cleared Traditional

QUANTASE TOTAL GALACTOSE SCREENING ASSAY

K990644 · Quantase , Ltd. · Chemistry
Jun 1999
Decision
115d
Days
Class 1
Risk

About This 510(k) Submission

K990644 is an FDA 510(k) clearance for the QUANTASE TOTAL GALACTOSE SCREENING ASSAY, 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, 115 days after receiving the submission on February 26, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1310.

Submission Details

510(k) Number K990644 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1999
Decision Date June 21, 1999
Days to Decision 115 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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