Cleared Traditional

K943592 - CHEMSTRIP MINI UA URINE ANALYZER

K943592 is an FDA 510(k) clearance for CHEMSTRIP MINI UA URINE ANALYZER, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code KQO cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K943592 · Boehringer Mannheim Corp. · Chemistry device
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Nov 1994
Decision
106d
Days
Class 1
Risk

K943592 is an FDA 510(k) clearance for the CHEMSTRIP MINI UA URINE ANALYZER. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 8, 1994 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2900 - 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K943592

510(k) Number K943592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1994
Decision Date November 08, 1994
Days to Decision 106 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 88d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

KQO Device Classification - Class 1, General Controls

Product Code KQO Automated Urinalysis System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KQO Automated Urinalysis System

All 23
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K943592.
STC DIAGNOSTICS AUTO-LYTE PH ASSAY
K954158 · Solarcare Technologies Corp,Inc. · Apr 1996
CHEMSTRIP CRITERION URINE ANALYZER
K954024 · Boehringer Mannheim Corp. · Oct 1995
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER
K946183 · Heraeus Kulzer, Inc. · Feb 1995
CHEMSTRIP SUPER UA URINE ANALYZER
K934042 · Boehringer Mannheim Corp. · Oct 1993
CHEMSTRIP URINE ANALYZER
K931602 · Boehringer Mannheim Corp. · Jun 1993
CLINITEK 200+ URINE CHEMISTRY ANALYZER
K926359 · Heraeus Kulzer, Inc. · Jan 1993