Cleared Traditional

URIDROP SPECIAL (K791197) - FDA 510(k) Clearance

Class I Chemistry device.

K791197 · Ab Medett Produkter · Chemistry device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Jul 1979

Decision

34d

Days

Class 1

Risk

K791197 is an FDA 510(k) clearance for the URIDROP SPECIAL. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Ab Medett Produkter (Mchenry, US). The FDA issued a Cleared decision on July 30, 1979 after a review of 34 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 Ab Medett Produkter devices

Submission Details

510(k) Number	K791197 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 26, 1979
Decision Date	July 30, 1979
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

54d faster than avg

Panel avg: 88d · This submission: 34d

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 35

Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K791197.

AMES SERA-PAK URIC ACID REAGENT KIT

K802724 · Miles Laboratories, Inc. · Dec 1980

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES

K801649 · Eastman Kodak Company · Aug 1980

SERALYZER URIC ACID REAGENT STRIPS -

K800848 · Miles Laboratories, Inc. · Apr 1980

URIC ACID, BOUND ENZYME

K790092 · Technicon Instruments Corp. · Mar 1979

URIC ACID TEST, BMC AUTOFLO

K770272 · Boehringer Mannheim Corp. · Mar 1977

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 K791197

Ab Medett Produkter

Mchenry, IL · US

Regulatory profile

3 submissions 3 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

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.

Verify on FDA.gov

Other 510(k) devices by Ab Medett Produkter

510k Database

510(k) clearances indexed 175,218

Regulatory data since 1976

FDA monthly sync Active