ACS CARDIO-TROL CONTROL

Multi-analyte Controls, All Kinds (assayed)

ANALYTICAL CONTROL SYSTEMS, INC.

The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs Cardio-trol Control.

Pre-market Notification Details

Device IDK941115
510k NumberK941115
Device Name:ACS CARDIO-TROL CONTROL
ClassificationMulti-analyte Controls, All Kinds (assayed)
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 CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-07
Decision Date1994-07-20

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