Cleared Traditional

JAS URIC ACID LIQUID REAGENT

K012038 · Jas Diagnostics, Inc. · Chemistry
Aug 2001
Decision
53d
Days
Class 1
Risk

About This 510(k) Submission

K012038 is an FDA 510(k) clearance for the JAS URIC ACID LIQUID REAGENT, a Acid, Uric, Uricase (colorimetric) (Class I — General Controls, product code KNK), submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on August 21, 2001, 53 days after receiving the submission on June 29, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K012038 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2001
Decision Date August 21, 2001
Days to Decision 53 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code KNK — Acid, Uric, Uricase (colorimetric)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1775

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