Cleared Traditional

K894173 - BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO...

K894173 is the FDA 510(k) clearance for BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO... by Catachem, Inc.. It is a Class 2 Chemistry device (product code CDQ) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K894173 · Catachem, Inc. · Chemistry device
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Sep 1989
Decision
82d
Days
Class 2
Risk

K894173 is an FDA 510(k) clearance for the BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Catachem, Inc. (Port Chester, US). The FDA issued a Cleared decision on September 5, 1989 after a review of 82 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 Catachem, Inc. devices

Submission Details

510(k) Number K894173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1989
Decision Date September 05, 1989
Days to Decision 82 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
6d faster than avg
Panel avg: 88d · This submission: 82d
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 K894173.
AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583
K900394 · American Research Products Co. · Apr 1990
DART UREA NITROGEN
K894836 · Coulter Electronics, Inc. · Oct 1989
BUN (KINETIC)
K895666 · Boehringer Mannheim Corp. · Oct 1989
UREA NITROGEN TEST (BUN) ITEM #65408
K894378 · Em Diagnostic Systems, Inc. · Aug 1989
ENZYMATIC UREA NITROGEN REAGENT SET
K892331 · American Monitor Corp. · Jun 1989
AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123
K891912 · American Research Products Co. · Jun 1989