Cleared Traditional

TECHNICON CHEM 1(TM) SYST (GEN2 SYST)

K914888 · Technicon Instruments Corp. · Chemistry
Nov 1991
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K914888 is an FDA 510(k) clearance for the TECHNICON CHEM 1(TM) SYST (GEN2 SYST), a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on November 27, 1991, 28 days after receiving the submission on October 30, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K914888 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 1991
Decision Date November 27, 1991
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CIX — Bromcresol Green Dye-binding, Albumin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1035

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