ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III

Single (specified) Analyte Controls (assayed And Unassayed)

ANALYTICAL CONTROL SYSTEMS, INC.

The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs Therapeutic Drug Monitoring Control, Level Iii.

Pre-market Notification Details

Device IDK911178
510k NumberK911178
Device Name:ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers,  IN  46038
ContactPauline W Bonderman
CorrespondentPauline W Bonderman
ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers,  IN  46038
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-18
Decision Date1991-05-01

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