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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Urinalysis System
510(k) Number K030600
Device Name AUTION JET AJ-4270 URINE ANALYZER
Applicant
International Remote Imaging Systems
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA J.M. NOLTE
Correspondent
International Remote Imaging Systems
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA J.M. NOLTE
Regulation Number862.2900
Classification Product Code
KQO  
Subsequent Product Codes
JIL   JIO  
Date Received02/25/2003
Decision Date 07/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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