Cleared Traditional

TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC

K901693 · Technicon Instruments Corp. · Chemistry
Apr 1990
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K901693 is an FDA 510(k) clearance for the TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC, a Acid, Uric, Uricase (colorimetric) (Class I — General Controls, product code KNK), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on April 25, 1990, 14 days after receiving the submission on April 11, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K901693 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1990
Decision Date April 25, 1990
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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