Cleared Traditional

K832201 - CHROM-PREP

K832201 is the FDA 510(k) clearance for CHROM-PREP by Hamilton Co.. It is a Class 1 Toxicology device (product code KZR) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K832201 · Hamilton Co. · Toxicology device
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Aug 1983
Decision
40d
Days
Class 1
Risk

K832201 is an FDA 510(k) clearance for the CHROM-PREP. Classified as Chromatography (liquid, Gel), Clinical Use (product code KZR), Class I - General Controls.

Submitted by Hamilton Co. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1983 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2260 - the FDA toxicology device 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 Hamilton Co. devices

Submission Details

510(k) Number K832201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1983
Decision Date August 16, 1983
Days to Decision 40 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 87d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZR Chromatography (liquid, Gel), Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2260
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 - KZR Chromatography (liquid, Gel), Clinical Use

All 11
Devices cleared under the same product code (KZR) and FDA review panel - the closest regulatory comparables to K832201.
LIQUID CHROMATOGRAPH 400
K843568 · The Perkin-Elmer Corp. · Nov 1984
VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY
K841890 · Varian Assoc., Inc. · Jun 1984
LIQUID CHROMATOGRAPHIC DETECTOR LC-95
K840977 · The Perkin-Elmer Corp. · Apr 1984
VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS
K802725 · Varian Assoc., Inc. · Dec 1980
LIQUID CHROMATOGRAPH MODEL 850
K780944 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1978
LIQUID CHROMATOGRAPH MODEL 860
K780945 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1978