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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K910930
Device Name ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1
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
DIF  
Date Received03/06/1991
Decision Date 05/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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