Cleared Traditional

CDM

K960392 · Bio-Rad · Chemistry
Jul 1996
Decision
161d
Days
Class 1
Risk

About This 510(k) Submission

K960392 is an FDA 510(k) clearance for the CDM, 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 July 8, 1996, 161 days after receiving the submission on January 29, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K960392 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 1996
Decision Date July 08, 1996
Days to Decision 161 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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