Cleared Traditional

AMRESCO UREA NITROGEN REAGENT SET (K830555) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K830555 · Amresco, Inc. · Chemistry device
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Mar 1983
Decision
29d
Days
Class 2
Risk

K830555 is an FDA 510(k) clearance for the AMRESCO UREA NITROGEN REAGENT SET. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Amresco, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 29 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 Amresco, Inc. devices

Submission Details

510(k) Number K830555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1983
Decision Date March 24, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
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 26
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K830555.
TDX REA BUN
K853677 · Abbott Laboratories · Sep 1985
FOCUS UREA NITROGEN
K844755 · Abbott Laboratories · Jan 1985
SYSTEMATE BUN HEM NO. 67221
K843326 · Em Diagnostic Systems, Inc. · Sep 1984
LANCER MSA BUN DIAG. KIT
K821562 · Sherwood Medical Co. · Jun 1982
FUN-UV SYSTEM PACK TEST
K812290 · Boehringer Mannheim Corp. · Aug 1981
A-GENT UREA NITROGEN
K810794 · Abbott Laboratories · Apr 1981