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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 K921118
Device Name ACS APCT REAGENT
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 Number864.7925
Classification Product Code
GFO  
Date Received03/09/1992
Decision Date 07/28/1992
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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