ACS CHOLESTEROL/TRIGLYCERIDE LIQUID 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 Cholesterol/triglyceride Liquid Control.

Pre-market Notification Details

Device IDK904829
510k NumberK904829
Device Name:ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant ANALYTICAL CONTROL SYSTEMS, INC. 155 E. MARKET, SUITE 502 Indianapolis,  IN  46204
ContactPauline W Bonderman
CorrespondentPauline W Bonderman
ANALYTICAL CONTROL SYSTEMS, INC. 155 E. MARKET, SUITE 502 Indianapolis,  IN  46204
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-10-25
Decision Date1990-12-06

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