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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 K911176
Device Name ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I
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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