Cleared Traditional

K942984 - BUN REAGENT

K942984 is the FDA 510(k) clearance for BUN REAGENT by American Research Products Co.. It is a Class 2 Chemistry device (product code CDQ) cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K942984 · American Research Products Co. · Chemistry device
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Mar 1995
Decision
254d
Days
Class 2
Risk

K942984 is an FDA 510(k) clearance for the BUN REAGENT. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on March 1, 1995 after a review of 254 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all American Research Products Co. devices

Submission Details

510(k) Number K942984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1994
Decision Date March 01, 1995
Days to Decision 254 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 88d · This submission: 254d
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 87
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K942984.
UREA NITROGEN (BUN) LIQUI-UV
K962418 · Stanbio Laboratory · Dec 1996
ROCHE REAGENT FOR BUN
K954000 · Roche Diagnostic Systems, Inc. · Oct 1995
BLOOD UREA NITROGEN REAGENT SYSTEM
K952742 · Medical Diagnostic Technologies, Inc. · Aug 1995
UREA KIT
K923506 · Randox Laboratories, Ltd. · Sep 1993
UREA NITROGEN TEST ITEM NUMBER 65408
K932161 · Em Diagnostic Systems, Inc. · Sep 1993
OLYMPUS REPLY UREA NITROGEN REAGENT
K931745 · Olympus Corp. · Aug 1993