Cleared Traditional

K781899 - UREA NITROGEN TEST

K781899 is an FDA 510(k) clearance for UREA NITROGEN TEST, manufactured by Wako Intl., Inc.. The device is a Class 2 Chemistry device with product code CDL cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K781899 · Wako Intl., Inc. · Chemistry device
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Dec 1978
Decision
37d
Days
Class 2
Risk

K781899 is an FDA 510(k) clearance for the UREA NITROGEN TEST. Classified as Berthelot Indophenol, Urea Nitrogen (product code CDL), Class II - Special Controls.

Submitted by Wako Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1978 after a review of 37 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 Wako Intl., Inc. devices

FDA 510(k) Submission Details - K781899

510(k) Number K781899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1978
Decision Date December 20, 1978
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDL Device Classification - Class 2, Special Controls

Product Code CDL Berthelot Indophenol, 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 - CDL Berthelot Indophenol, Urea Nitrogen

All 13
Devices cleared under the same product code (CDL) and FDA review panel - the closest regulatory comparables to K781899.
DATA-ZYME UREA NITROGEN, COLORIMETRIC
K801727 · Data Medical Associates, Inc. · Sep 1980
BUN-COLOR 2, BLOOD UREA NITROGEN TEST
K800902 · Sclavo, Inc. · Jun 1980
ELVI BLOOD UREA NITROGEN
K792417 · Volu Sol Medical Industries · Dec 1979
S-UREA-N, IN VITRO DIAG FOR BUN
K761152 · Advanced Biomedical Methods, Inc. · Dec 1976