Cleared Traditional

K791754 - URIC ACID REAGENT

K791754 is an FDA 510(k) clearance for URIC ACID REAGENT, manufactured by Gilford Diagnostics. The device is a Class 1 Chemistry device with product code KNK cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K791754 · Gilford Diagnostics · Chemistry device
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Sep 1979
Decision
22d
Days
Class 1
Risk

K791754 is an FDA 510(k) clearance for the URIC ACID REAGENT. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Gilford Diagnostics (Mchenry, US). The FDA issued a Cleared decision on September 27, 1979 after a review of 22 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.

FDA 510(k) Submission Details - K791754

510(k) Number K791754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1979
Decision Date September 27, 1979
Days to Decision 22 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
67d faster than avg
Panel avg: 89d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

KNK Device Classification - Class 1, General Controls

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 116
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K791754.
URIC ACID DIAGNOSTIC REAGENT
K801898 · Connecticut Diagnostics, Ltd. · Oct 1980
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K801649 · Eastman Kodak Company · Aug 1980
SERALYZER URIC ACID REAGENT STRIPS -
K800848 · Miles Laboratories, Inc. · Apr 1980
URIDROP SPECIAL
K791197 · Ab Medett Produkter · Jul 1979
FLOZYME* URIC ACID REAGENT
K790486 · Worthington Diagnostic Systems · Apr 1979
URIC ACID, BOUND ENZYME
K790092 · Technicon Instruments Corp. · Mar 1979
K791754 · URIC ACID REAGENT
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