Cleared Traditional

BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM

K942451 · Bio-Rad · Chemistry
Nov 1994
Decision
171d
Days
Class 1
Risk

About This 510(k) Submission

K942451 is an FDA 510(k) clearance for the BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM, a Instrumentation, High Pressure Liquid Chromatography (Class I — General Controls, product code LDM), submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on November 10, 1994, 171 days after receiving the submission on May 23, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K942451 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 1994
Decision Date November 10, 1994
Days to Decision 171 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code LDM — Instrumentation, High Pressure Liquid Chromatography
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2260

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