Cleared Traditional

TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES

K902243 · Technicon Instruments Corp. · Chemistry
Jul 1990
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K902243 is an FDA 510(k) clearance for the TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES, a Enzyme Immunoassay, Theophylline (Class II — Special Controls, product code KLS), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on July 5, 1990, 48 days after receiving the submission on May 18, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K902243 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 1990
Decision Date July 05, 1990
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KLS — Enzyme Immunoassay, Theophylline
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3880

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