Cleared Traditional

K800902 - BUN-COLOR 2

K800902 is the FDA 510(k) clearance for BUN-COLOR 2 by Sclavo, Inc.. It is a Class 2 Chemistry device (product code CDL) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K800902 · Sclavo, Inc. · Chemistry device
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Jun 1980
Decision
52d
Days
Class 2
Risk

K800902 is an FDA 510(k) clearance for the BUN-COLOR 2, BLOOD UREA NITROGEN TEST. Classified as Berthelot Indophenol, Urea Nitrogen (product code CDL), Class II - Special Controls.

Submitted by Sclavo, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980 after a review of 52 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 Sclavo, Inc. devices

Submission Details

510(k) Number K800902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1980
Decision Date June 09, 1980
Days to Decision 52 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
36d faster than avg
Panel avg: 88d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (CDL) and FDA review panel - the closest regulatory comparables to K800902.
BUN (ENZYMATIC BERTHELOT) REAGENT SET
K860154 · Sterling Diagnostics, Inc. · Feb 1986
EUROCHIMA UREA NITROGEN
K810261 · Volu Sol Medical Industries · Feb 1981
DATA-ZYME UREA NITROGEN, COLORIMETRIC
K801727 · Data Medical Associates, Inc. · Sep 1980
ELVI BLOOD UREA NITROGEN
K792417 · Volu Sol Medical Industries · Dec 1979