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510(k) K911178

ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III by Analytical Control Systems, Inc. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1991
Date Received
March 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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  • K921223 — ACS FREEZE-DRIED APTT REAGENT (August 18, 1992)
  • K921118 — ACS APCT REAGENT (July 28, 1992)

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