DIRECT BILIRUBIN PROCEDURE

Diazo Colorimetry, Bilirubin

DATA MEDICAL ASSOCIATES, INC.

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

Pre-market Notification Details

Device IDK863265
510k NumberK863265
Device Name:DIRECT BILIRUBIN PROCEDURE
ClassificationDiazo Colorimetry, Bilirubin
Applicant DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
ContactMarjorie B Potts
CorrespondentMarjorie B Potts
DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
Product CodeCIG  
CFR Regulation Number862.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-25
Decision Date1986-10-24

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