Cleared Traditional

K832439 - CREATININE REAGENT SET

K832439 is an FDA 510(k) clearance for CREATININE REAGENT SET, manufactured by Amresco, Inc.. The device is a Class 2 Chemistry device with product code CGX cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K832439 · Amresco, Inc. · Chemistry device
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Jan 1984
Decision
176d
Days
Class 2
Risk

K832439 is an FDA 510(k) clearance for the CREATININE REAGENT SET. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Amresco, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1984 after a review of 176 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 Amresco, Inc. devices

FDA 510(k) Submission Details - K832439

510(k) Number K832439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1983
Decision Date January 17, 1984
Days to Decision 176 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
88d slower than avg
Panel avg: 88d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGX Device Classification - Class 2, Special Controls

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGX Alkaline Picrate, Colorimetry, Creatinine

All 143
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K832439.
SYSTEMATE CREATININE 67223
K843105 · Em Diagnostic Systems, Inc. · Aug 1984
CREATININE ASSAY KIT-KINETIC OR ENDPOINT
K842159 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
RAICHEM CREATININE REAGENT
K840872 · Reagents Applications, Inc. · Apr 1984
CREATININE REAGENTS B6360-10
K831627 · American Scientific Products · Jul 1983
CREATININE REAGENTS B6370-13
K831628 · American Scientific Products · Jul 1983
KINETIC CREATININE
K830447 · American Monitor Corp. · Mar 1983