Cleared Traditional

K850933 - URIC ACID

K850933 is an FDA 510(k) clearance for URIC ACID, manufactured by Dilab, Inc.. The device is a Class 1 Chemistry device with product code CDH cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K850933 · Dilab, Inc. · Chemistry device
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Jun 1985
Decision
110d
Days
Class 1
Risk

K850933 is an FDA 510(k) clearance for the URIC ACID. Classified as Acid, Uric, Phosphotungstate Reduction (product code CDH), Class I - General Controls.

Submitted by Dilab, Inc. (Miami, US). The FDA issued a Cleared decision on June 25, 1985 after a review of 110 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Dilab, Inc. devices

FDA 510(k) Submission Details - K850933

510(k) Number K850933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1985
Decision Date June 25, 1985
Days to Decision 110 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 88d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

CDH Device Classification - Class 1, General Controls

Product Code CDH Acid, Uric, Phosphotungstate Reduction
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 - CDH Acid, Uric, Phosphotungstate Reduction

All 13
Devices cleared under the same product code (CDH) and FDA review panel - the closest regulatory comparables to K850933.
URIC ACID REAGENT SET
K841067 · Medical Specialties, Inc. · May 1984
URIC ACID REAGENT SET
K821213 · Omega Medical Electronics · Jul 1982
PHOSPHOTUNGSTATE REDUCTION, URIC ACID
K813076 · American Monitor Corp. · Nov 1981
URIC ACID (TPTZ) COLORINMETRIC
K810088 · Bio-Analytics Laboratories, Inc. · Jan 1981
SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC
K800672 · Diagnostic Solutions, Inc. · May 1980
STANBIO DIRECT URIC ACID TEST SET #0770
K800190 · Stanbio Laboratory · Feb 1980