AUTION MAX AX-4280 URINALYSIS SYSTEM

Automated Urinalysis System

INTERNATIONAL REMOTE IMAGING SYSTEMS

The following data is part of a premarket notification filed by International Remote Imaging Systems with the FDA for Aution Max Ax-4280 Urinalysis System.

Pre-market Notification Details

Device IDK013783
510k NumberK013783
Device Name:AUTION MAX AX-4280 URINALYSIS SYSTEM
ClassificationAutomated Urinalysis System
Applicant INTERNATIONAL REMOTE IMAGING SYSTEMS 49 PLAIN ST. North Attleboro,  MA  02760
ContactCynthia J.m Nolte
CorrespondentCynthia J.m Nolte
INTERNATIONAL REMOTE IMAGING SYSTEMS 49 PLAIN ST. North Attleboro,  MA  02760
Product CodeKQO  
Subsequent Product CodeCDM
Subsequent Product CodeCEN
Subsequent Product CodeJIL
Subsequent Product CodeJIN
Subsequent Product CodeJIO
Subsequent Product CodeJIR
Subsequent Product CodeJJB
Subsequent Product CodeJMT
Subsequent Product CodeJRE
Subsequent Product CodeLJX
CFR Regulation Number862.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-11-14
Decision Date2002-01-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987486001959 K013783 000

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