Cleared Traditional

K953077 - PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM (FDA 510(k) Clearance)

Class I Chemistry device.

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

K953077 is an FDA 510(k) clearance for the PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM. Classified as Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin (product code CDF), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on January 5, 1996 after a review of 189 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1795 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Instruments, Inc. devices

Submission Details

510(k) Number K953077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 88d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDF Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1795
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.