Cleared Traditional

K840064 - UREA NITROGEN REAGENT SET

K840064 is the FDA 510(k) clearance for UREA NITROGEN REAGENT SET by Sterling Biochemical, Inc.. It is a Class 2 Chemistry device (product code CDQ) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K840064 · Sterling Biochemical, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1984
Decision
157d
Days
Class 2
Risk

K840064 is an FDA 510(k) clearance for the UREA NITROGEN REAGENT SET. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Sterling Biochemical, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1984 after a review of 157 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 Sterling Biochemical, Inc. devices

Submission Details

510(k) Number K840064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1984
Decision Date June 14, 1984
Days to Decision 157 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 88d · This submission: 157d
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 89
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K840064.
SYSTEMATE BUN HEM NO. 67221
K843326 · Em Diagnostic Systems, Inc. · Sep 1984
UREA ASSAY KIT
K843057 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
UREA ASSAY KIT
K842242 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984
PARAMAX UREA NITROGEN REAGENT
K840785 · American Dade · Apr 1984
BUN LIQUID STABLE REAGENT SET
K832941 · Medical Analysis Systems, Inc. · Oct 1983
ULTRA CHEM BUN-UV #65080-65081
K830241 · Emd Chemicals, Inc. · Apr 1983