Cleared Traditional

TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD

K903305 · Technicon Instruments Corp. · Chemistry
Sep 1990
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K903305 is an FDA 510(k) clearance for the TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on September 27, 1990, 65 days after receiving the submission on July 24, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K903305 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1990
Decision Date September 27, 1990
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KHS — Enzymatic, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160

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