DIRECT BILIRUBEN CALIBRATIONS

Calibrator, Secondary

DATA MEDICAL ASSOCIATES, INC.

The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Direct Biliruben Calibrations.

Pre-market Notification Details

Device IDK852067
510k NumberK852067
Device Name:DIRECT BILIRUBEN CALIBRATIONS
ClassificationCalibrator, Secondary
Applicant DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
ContactJerry A Graham
CorrespondentJerry A Graham
DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-10
Decision Date1985-05-31

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