Cleared Traditional

K850937 - UREA

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

K850937 · Dilab, Inc. · Chemistry device
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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

FDA 510(k) Submission Details - K850937

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.

CDW Device Classification - Class 2, Special Controls

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 15
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
ULTRACHEM BUN-UV, 65080 & 65081
K822323 · Harleco Diagnostics · Sep 1982
UREA NITROGEN REAGENT SET
K821212 · Omega Medical Electronics · Jul 1982