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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Plasma, Abnormal
510(k) Number K894425
Device Name ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III
Applicant
Analytical Control Systems, Inc.
155 E. Market, Suite 502
Indianapolis,  IN  46204
Applicant Contact W BONDERMAN
Correspondent
Analytical Control Systems, Inc.
155 E. Market, Suite 502
Indianapolis,  IN  46204
Correspondent Contact W BONDERMAN
Regulation Number864.5425
Classification Product Code
GGC  
Date Received07/17/1989
Decision Date 08/03/1989
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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