Cleared Traditional

TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES

K912616 · Technicon Instruments Corp. · Chemistry
Sep 1991
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K912616 is an FDA 510(k) clearance for the TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES, a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II — Special Controls, product code KLI), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on September 25, 1991, 104 days after receiving the submission on June 13, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K912616 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 1991
Decision Date September 25, 1991
Days to Decision 104 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

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