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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 K926012
Device Name ACS APCT REAGENT, MODIFIED
Applicant
Analytical Control Systems, Inc.
9058 Technology Dr.
Fishers,  IN  46038
Applicant Contact ROY SPECK
Correspondent
Analytical Control Systems, Inc.
9058 Technology Dr.
Fishers,  IN  46038
Correspondent Contact ROY SPECK
Regulation Number864.7925
Classification Product Code
GFO  
Date Received11/20/1992
Decision Date 04/27/1993
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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