Cleared Traditional

K850937 - UREA

K850937 is the FDA 510(k) clearance for UREA by Dilab, Inc.. It is a Class 2 Chemistry device (product code CDW) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K850937 · Dilab, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
95d
Days
Class 2
Risk

K850937 is an FDA 510(k) clearance for the UREA. Classified as Diacetyl-monoxime, Urea Nitrogen (product code CDW), Class II - Special Controls.

Submitted by Dilab, Inc. (Miami, US). The FDA issued a Cleared decision on June 10, 1985 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - 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 K850937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1985
Decision Date June 10, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 88d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDW Diacetyl-monoxime, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CDW Diacetyl-monoxime, Urea Nitrogen

All 9
Devices cleared under the same product code (CDW) and FDA review panel - the closest regulatory comparables to K850937.
AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346
K863425 · American Research Products Co. · Oct 1986
TWIN BUN/GLUCOSE
K861775 · Boehringer Mannheim Corp. · Jun 1986
UREA NITROGEN REAGENT SET
K860419 · Sterling Diagnostics, Inc. · Feb 1986
UREA NITROGEN REAGENT SET
K841068 · Medical Specialties, Inc. · May 1984
SERUM, BLOOD UREA NITIOGEN
K781885 · Fisher Scientific Co., LLC · Dec 1978
BLOOD UREA NITROGEN (BUN) REAGENT
K771312 · Mallinckrodt Critical Care · Aug 1977