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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Control, Normal
510(k) Number K893784
Device Name ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I
Applicant
ANALYTICAL CONTROL SYSTEMS, INC.
9001 TECHNOLOGY DR.
SUITE A
FISHERS,  IN  46060
Applicant Contact PAULINE W BONDERMAN
Correspondent
ANALYTICAL CONTROL SYSTEMS, INC.
9001 TECHNOLOGY DR.
SUITE A
FISHERS,  IN  46060
Correspondent Contact PAULINE W BONDERMAN
Regulation Number864.5425
Classification Product Code
GIZ  
Date Received05/22/1989
Decision Date 06/23/1989
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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