Cleared Traditional

K800128 - CENTRIFICHEM BUN

K800128 is an FDA 510(k) clearance for CENTRIFICHEM BUN, manufactured by Union Carbide Corp.. The device is a Class 2 Chemistry device with product code CDQ cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K800128 · Union Carbide Corp. · Chemistry device
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Feb 1980
Decision
26d
Days
Class 2
Risk

K800128 is an FDA 510(k) clearance for the CENTRIFICHEM BUN. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980 after a review of 26 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 Union Carbide Corp. devices

FDA 510(k) Submission Details - K800128

510(k) Number K800128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1980
Decision Date February 13, 1980
Days to Decision 26 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
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDQ Device Classification - Class 2, Special Controls

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 90
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K800128.
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
BUN
K781782 · Gilford Diagnostics · Jan 1979
BUN TEST UNI-UV BLOOD UREA NITROGEN TEST
K780943 · Sclavo, Inc. · Jul 1978
BUN REAGNET SET
K780069 · Medical Analysis Systems, Inc. · Feb 1978