Cleared Traditional

TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE

K901122 · Technicon Instruments Corp. · Chemistry
Mar 1990
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K901122 is an FDA 510(k) clearance for the TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on March 29, 1990, 17 days after receiving the submission on March 12, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K901122 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 1990
Decision Date March 29, 1990
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CFR — Hexokinase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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