Cleared Traditional

K791180 - CENTRIFICHEM SYSTEM 500

K791180 is an FDA 510(k) clearance for CENTRIFICHEM SYSTEM 500, manufactured by Union Carbide Corp.. The device is a Class 1 Chemistry device with product code JJG cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K791180 · Union Carbide Corp. · Chemistry device
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Aug 1979
Decision
46d
Days
Class 1
Risk

K791180 is an FDA 510(k) clearance for the CENTRIFICHEM SYSTEM 500. Classified as Analyzer, Chemistry, Centrifugal, For Clinical Use (product code JJG), Class I - General Controls.

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1979 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2140 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Union Carbide Corp. devices

FDA 510(k) Submission Details - K791180

510(k) Number K791180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1979
Decision Date August 10, 1979
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

JJG Device Classification - Class 1, General Controls

Product Code JJG Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2140
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.

Regulatory Peers - JJG Analyzer, Chemistry, Centrifugal, For Clinical Use

All 19
Devices cleared under the same product code (JJG) and FDA review panel - the closest regulatory comparables to K791180.
CENTRIFICHEM SYSTEM 500 ANALYZER
K801139 · Union Carbide Corp. · Jun 1980
IL MODEL 773 FLUORESCENCE LIGHT SCATTER
K801026 · Instrumentation Laboratory CO · May 1980
COBAS-BIO CENTRIFUGAL ANALYZER
K792671 · Hoffmann-La Roche, Inc. · Jan 1980
CENTRIA SYSTEM
K790550 · Union Carbide Corp. · May 1979
ANALYZER, CENTRIFUCHEM SYSTEM 400
K790278 · Union Carbide Corp. · Apr 1979