Cleared Traditional

K850933 - URIC ACID

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

K850933 · Dilab, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 8
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
PHOSPHOTUNGSTATE REDUCTION, URIC ACID
K813076 · American Monitor Corp. · Nov 1981
STANBIO DIRECT URIC ACID TEST SET #0770
K800190 · Stanbio Laboratory · Feb 1980
ELVI URIC ACID-COLORIMETRIC METHOD
K792403 · Volu Sol Medical Industries · Dec 1979
ELVI URIC ACID
K792412 · Volu Sol Medical Industries · Dec 1979
SERUM, URIC ACID DETERMINATION
K790019 · Fisher Scientific Co., LLC · Feb 1979