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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Specific Control Materials
510(k) Number K913677
Device Name ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III
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 Number862.3280
Classification Product Code
LAS  
Date Received08/19/1991
Decision Date 09/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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