Cleared Traditional

K811504 - WAKO URIC ACID B TEST

K811504 is an FDA 510(k) clearance for WAKO URIC ACID B TEST, manufactured by Wako Chemicals USA, Inc.. The device is a Class 1 Chemistry device with product code KNK cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K811504 · Wako Chemicals USA, Inc. · Chemistry device
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Jun 1981
Decision
13d
Days
Class 1
Risk

K811504 is an FDA 510(k) clearance for the WAKO URIC ACID B TEST. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1981 after a review of 13 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 - K811504

510(k) Number K811504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1981
Decision Date June 09, 1981
Days to Decision 13 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
76d faster than avg
Panel avg: 89d · This submission: 13d
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 117
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K811504.
URIC ACID TEST
K811810 · Environmental Chemical Specialties · Jul 1981
SELECT-A-FLOW
K811857 · Wenmar Intl. Corp. · Jul 1981
URIC ACID TEST
K811687 · King Diagnostics, Inc. · Jul 1981
URIC ACID REAGENT SYSTEM
K810136 · American Monitor Corp. · Feb 1981
LANCER URIC ACID AUTO/STAT KIT
K802692 · Sherwood Medical Co. · Dec 1980
AMES SERA-PAK URIC ACID REAGENT KIT
K802724 · Miles Laboratories, Inc. · Dec 1980
K811504 · WAKO URIC ACID B TEST
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