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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K882559
Device Name PROFILE ONE OMNI
Applicant
MODULAR DIAGNOSTIC SYSTEMS, INC.
227 WEST FAYETTE ST.
SYRACUSE,  NY  13202
Applicant Contact JEFFREY A DUBOIS
Correspondent
MODULAR DIAGNOSTIC SYSTEMS, INC.
227 WEST FAYETTE ST.
SYRACUSE,  NY  13202
Correspondent Contact JEFFREY A DUBOIS
Regulation Number862.2160
Classification Product Code
JJE  
Date Received06/21/1988
Decision Date 08/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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