Cleared Traditional

K841068 - UREA NITROGEN REAGENT SET

K841068 is the FDA 510(k) clearance for UREA NITROGEN REAGENT SET by Medical Specialties, Inc.. It is a Class 2 Chemistry device (product code CDW) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K841068 · Medical Specialties, Inc. · Chemistry device
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May 1984
Decision
50d
Days
Class 2
Risk

K841068 is an FDA 510(k) clearance for the UREA NITROGEN REAGENT SET. Classified as Diacetyl-monoxime, Urea Nitrogen (product code CDW), Class II - Special Controls.

Submitted by Medical Specialties, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1984 after a review of 50 days - a notably fast clearance cycle.

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: 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 Medical Specialties, Inc. devices

Submission Details

510(k) Number K841068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1984
Decision Date May 01, 1984
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 88d · This submission: 50d
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 8
Devices cleared under the same product code (CDW) and FDA review panel - the closest regulatory comparables to K841068.
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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
SERUM, BLOOD UREA NITIOGEN
K781885 · Fisher Scientific Co., LLC · Dec 1978
BLOOD UREA NITROGEN (BUN) REAGENT
K771312 · Mallinckrodt Critical Care · Aug 1977
UNIPAK BUN
K771087 · Harleco · Jul 1977