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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Hematocrit, Automated
510(k) Number K870860
Device Name CHEMPRO 1000(TM)
Applicant
Arden Medical Systems, Inc.
3771 Lexington Ave. N.
Arden Hills,  MN  55126
Applicant Contact WALTER SEMBROWICH
Correspondent
Arden Medical Systems, Inc.
3771 Lexington Ave. N.
Arden Hills,  MN  55126
Correspondent Contact WALTER SEMBROWICH
Regulation Number864.5600
Classification Product Code
GKF  
Date Received03/03/1987
Decision Date 04/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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