Cleared Traditional

K932161 - UREA NITROGEN TEST ITEM NUMBER 65408

K932161 is an FDA 510(k) clearance for UREA NITROGEN TEST ITEM NUMBER 65408, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CDQ cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K932161 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1993
Decision
127d
Days
Class 2
Risk

K932161 is an FDA 510(k) clearance for the UREA NITROGEN TEST ITEM NUMBER 65408. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on September 8, 1993 after a review of 127 days - within the typical 510(k) review window.

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 Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K932161

510(k) Number K932161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1993
Decision Date September 08, 1993
Days to Decision 127 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
39d slower than avg
Panel avg: 88d · This submission: 127d
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 106
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K932161.
BLOOD UREA NITROGEN REAGENT SYSTEM
K952742 · Medical Diagnostic Technologies, Inc. · Aug 1995
BUN REAGENT
K942984 · American Research Products Co. · Mar 1995
UREA KIT
K923506 · Randox Laboratories, Ltd. · Sep 1993
OLYMPUS REPLY UREA NITROGEN REAGENT
K931745 · Olympus Corp. · Aug 1993
UREA NITROGEN TEST
K925002 · Em Diagnostic Systems, Inc. · Jan 1993
OLYMPUS BUN REAGENT
K924693 · Olympus Corp. · Nov 1992