939UDX URINE PATHOLOGY SYSTEM

Counter, Urine Particle

INTL. REMOTE IMAGING SYSTEMS

The following data is part of a premarket notification filed by Intl. Remote Imaging Systems with the FDA for 939udx Urine Pathology System.

Pre-market Notification Details

Device IDK000373
510k NumberK000373
Device Name:939UDX URINE PATHOLOGY SYSTEM
ClassificationCounter, Urine Particle
Applicant INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth,  CA  91311
ContactHarvey L Kasdan
CorrespondentHarvey L Kasdan
INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth,  CA  91311
Product CodeLKM  
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-04
Decision Date2000-04-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.