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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K904829
Device Name ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL
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 Number862.1660
Classification Product Code
JJY  
Date Received10/25/1990
Decision Date 12/06/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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