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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 K893970
Device Name ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II
Applicant
Analytical Control Systems, Inc.
9001 Technology Dr.
Suite A
Fishers,  IN  46060
Applicant Contact PAULINE BONDERMAN
Correspondent
Analytical Control Systems, Inc.
9001 Technology Dr.
Suite A
Fishers,  IN  46060
Correspondent Contact PAULINE BONDERMAN
Regulation Number864.5425
Classification Product Code
GGC  
Date Received06/02/1989
Decision Date 07/25/1989
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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