Cleared Traditional

K822154 - UREA NITROGEN (ENZYMATIC) DETERMINATION

K822154 is the FDA 510(k) clearance for UREA NITROGEN (ENZYMATIC) DETERMINATION by The Dow Chemical Co.. It is a Class 2 Chemistry device (product code CDN) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K822154 · The Dow Chemical Co. · Chemistry device
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Aug 1982
Decision
13d
Days
Class 2
Risk

K822154 is an FDA 510(k) clearance for the UREA NITROGEN (ENZYMATIC) DETERMINATION. Classified as Urease, Photometric, Urea Nitrogen (product code CDN), Class II - Special Controls.

Submitted by The Dow Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on August 5, 1982 after a review of 13 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 The Dow Chemical Co. devices

Submission Details

510(k) Number K822154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1982
Decision Date August 05, 1982
Days to Decision 13 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 88d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDN Urease, Photometric, 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 - CDN Urease, Photometric, Urea Nitrogen

All 8
Devices cleared under the same product code (CDN) and FDA review panel - the closest regulatory comparables to K822154.
EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)
K961196 · Johnson & Johnson Clinical Diagnostics, Inc. · May 1996
KING DIAGNOSTICS UREA NITROGEN REAGENT
K922969 · King Diagnostics, Inc. · Oct 1992
QUICKSTART UREA NITROGEN
K914903 · Em Diagnostic Systems, Inc. · Dec 1991
STATTEK BUN
K792328 · Boehringer Mannheim Corp. · Dec 1979
BUN (UREASE) REAGENT
K781253 · Coulter Electronics, Inc. · Aug 1978
MULTISTAT III UREA NITROGEN TEST
K771442 · Instrumentation Laboratory CO · Aug 1977