Cleared Traditional

PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM

K953077 · Beckman Instruments, Inc. · Chemistry
Jan 1996
Decision
189d
Days
Class 1
Risk

About This 510(k) Submission

K953077 is an FDA 510(k) clearance for the PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM, a Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin (Class I — General Controls, product code CDF), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on January 5, 1996, 189 days after receiving the submission on June 30, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1795.

Submission Details

510(k) Number K953077 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 1995
Decision Date January 05, 1996
Days to Decision 189 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDF — Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1795

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