Cleared Traditional

K811504 - WAKO URIC ACID B TEST

K811504 is the FDA 510(k) clearance for WAKO URIC ACID B TEST by Wako Chemicals USA, Inc.. It is a Class 1 Chemistry device (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.

View all Wako Chemicals USA, Inc. devices

Submission Details

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
75d faster than avg
Panel avg: 88d · This submission: 13d
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 78
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K811504.
URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM
K812641 · Reagents Applications, Inc. · Oct 1981
URIC ACID REAGENT SET
K812430 · Pointe Scientific, Inc., · Sep 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