CHEM TRAK LIQUID BILIRUBIN CONTROL

Single (specified) Analyte Controls (assayed And Unassayed)

MEDICAL ANALYSIS SYSTEMS, INC.

The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Chem Trak Liquid Bilirubin Control.

Pre-market Notification Details

Device IDK833097
510k NumberK833097
Device Name:CHEM TRAK LIQUID BILIRUBIN CONTROL
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant MEDICAL ANALYSIS SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-12
Decision Date1984-01-11

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