Cleared Traditional

K800719 - ENZYMATIC UREA NITROGEN REAGENT SET REVI

K800719 is the FDA 510(k) clearance for ENZYMATIC UREA NITROGEN REAGENT SET REVI by Macomb Chemical Co.. It is a Class 2 Chemistry device (product code CDQ) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K800719 · Macomb Chemical Co. · Chemistry device
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May 1980
Decision
38d
Days
Class 2
Risk

K800719 is an FDA 510(k) clearance for the ENZYMATIC UREA NITROGEN REAGENT SET REVI. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Macomb Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on May 8, 1980 after a review of 38 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 Macomb Chemical Co. devices

Submission Details

510(k) Number K800719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1980
Decision Date May 08, 1980
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDQ Urease And Glutamic Dehydrogenase, 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 - CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

All 89
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K800719.
FUN-UV SYSTEM PACK TEST
K812290 · Boehringer Mannheim Corp. · Aug 1981
A-GENT UREA NITROGEN
K810794 · Abbott Laboratories · Apr 1981
DATA-ZYME UREA NITROGEN REAGENT SET
K802061 · Data Medical Associates, Inc. · Sep 1980
CENTRIFICHEM BUN
K800529 · Union Carbide Corp. · Mar 1980
BUN REAGENT
K800341 · Gilford Diagnostics · Mar 1980
CENTRIFICHEM BUN
K800128 · Union Carbide Corp. · Feb 1980