Cleared Traditional

K843938 - LINEAR ENZYMATIC URIC ACID SYSTEM

K843938 is the FDA 510(k) clearance for LINEAR ENZYMATIC URIC ACID SYSTEM by Simmler, Inc.. It is a Class 1 Chemistry device (product code KNK) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K843938 · Simmler, Inc. · Chemistry device
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Oct 1984
Decision
21d
Days
Class 1
Risk

K843938 is an FDA 510(k) clearance for the LINEAR ENZYMATIC URIC ACID SYSTEM. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Simmler, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 30, 1984 after a review of 21 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 Simmler, Inc. devices

Submission Details

510(k) Number K843938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1984
Decision Date October 30, 1984
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
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 K843938.
URIC ACID REAGENT
K853357 · Sigma Diagnostics, Inc. · Aug 1985
UN(UREASE)REAGENT UN(A-KETO)REAGENT
K851991 · Alpkem Corp. · May 1985
UA(URICASE) REAGENT
K852004 · Alpkem Corp. · May 1985
FOCUS URIC ACID
K844011 · Abbott Laboratories · Oct 1984
SYSTEMATE URIC ACID, HEM 67220
K843325 · Em Diagnostic Systems, Inc. · Sep 1984
URIC ACID ASSAY KIT
K842246 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984