Cleared Traditional

K820632 - COLORIMETRIC URIC ACID REAGENT SET

K820632 is the FDA 510(k) clearance for COLORIMETRIC URIC ACID REAGENT SET by Biorent Diagnostic, Inc.. It is a Class 1 Chemistry device (product code KNK) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K820632 · Biorent Diagnostic, Inc. · Chemistry device

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Mar 1982

Decision

17d

Days

Class 1

Risk

K820632 is an FDA 510(k) clearance for the COLORIMETRIC URIC ACID REAGENT SET. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Biorent Diagnostic, Inc. (Walker, US). The FDA issued a Cleared decision on March 25, 1982 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1775 - 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 Biorent Diagnostic, Inc. devices

Submission Details

510(k) Number	K820632 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 08, 1982
Decision Date	March 25, 1982
Days to Decision	17 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

71d faster than avg

Panel avg: 88d · This submission: 17d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	KNK Acid, Uric, Uricase (colorimetric)
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 862.1775

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 - KNK Acid, Uric, Uricase (colorimetric)

All 83

Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K820632.

DATA-ZYME URIC ACID PROCEDURE

K831983 · Data Medical Associates, Inc. · Aug 1983

URIC-ACID TEST ENZYMATIC COLORIMETRIC

K831864 · Stanbio Laboratory · Jul 1983

BECKMAN URIC ACID REAGENT

K821812 · Beckman Instruments, Inc. · Jul 1982

URIC-ACID

K813511 · Medical Analysis Systems, Inc. · Dec 1981

URIC ACID SYSTEM PACK TEST

K812978 · Boehringer Mannheim Corp. · Nov 1981

URICAR

K812700 · Hi Chem, Inc. · Nov 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K820632

Biorent Diagnostic, Inc.

Walker, MI · US

Regulatory profile

11 submissions 11 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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