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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K912102
Device Name ACS LIQUID THROMBOPLASTIN
Applicant
Analytical Control Systems, Inc.
155 E. Market, Suite 502
Indianapolis,  IN  46204
Applicant Contact PAULINE W BONDERMAN
Correspondent
Analytical Control Systems, Inc.
155 E. Market, Suite 502
Indianapolis,  IN  46204
Correspondent Contact PAULINE W BONDERMAN
Regulation Number864.7750
Classification Product Code
GJS  
Date Received05/13/1991
Decision Date 08/09/1991
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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