Cleared Traditional

CHEM-LINK DATA BASE MANAGER

K912413 · Technicon Instruments Corp. · Chemistry
Jul 1991
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K912413 is an FDA 510(k) clearance for the CHEM-LINK DATA BASE MANAGER, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on July 1, 1991, 31 days after receiving the submission on May 31, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K912413 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 1991
Decision Date July 01, 1991
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2300

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