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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Partial Thromboplastin
510(k) Number K902556
Device Name ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
Applicant
Analytical Control Systems, Inc.
9001 Technology Dr.
Suite A
Fishers,  IN  46060
Applicant Contact ROY SPECK
Correspondent
Analytical Control Systems, Inc.
9001 Technology Dr.
Suite A
Fishers,  IN  46060
Correspondent Contact ROY SPECK
Regulation Number864.7925
Classification Product Code
GFO  
Date Received06/08/1990
Decision Date 08/06/1990
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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