Cleared Traditional

CHEMSTRIP MINI UA URINE ANALYZER (K943592) - FDA 510(k) Clearance

Class I Chemistry device.

K943592 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 14
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K943592.
CHEMSTRIP 101 URINE ANALYZER
K983510 · Boehringer Mannheim Corp. · Oct 1998
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