Cleared Traditional

TECHNICON AXON SYSTEM REAGENT METHODS

K900905 · Technicon Instruments Corp. · Chemistry
Apr 1990
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K900905 is an FDA 510(k) clearance for the TECHNICON AXON SYSTEM REAGENT METHODS, a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I — General Controls, product code CKA), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on April 3, 1990, 35 days after receiving the submission on February 27, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K900905 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1990
Decision Date April 03, 1990
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CKA — Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1030

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