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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K911177
Device Name ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II
Applicant
Analytical Control Systems, Inc.
9058 Technology Dr.
Fishers,  IN  46038
Applicant Contact PAULINE W BONDERMAN
Correspondent
Analytical Control Systems, Inc.
9058 Technology Dr.
Fishers,  IN  46038
Correspondent Contact PAULINE W BONDERMAN
Regulation Number862.1660
Classification Product Code
JJX  
Date Received03/18/1991
Decision Date 05/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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