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510(k) K913677

ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III by Analytical Control Systems, Inc. — Product Code LAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1991
Date Received
August 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Specific Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

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