SERTROL PRODUCT # ACS ST 101

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 Sertrol Product # Acs St 101.

Pre-market Notification Details

Device IDK800559
510k NumberK800559
Device Name:SERTROL PRODUCT # ACS ST 101
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant ANALYTICAL CONTROL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-03-12
Decision Date1980-03-25

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