TOTAL 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 Total Bilirubin Procedure.

Pre-market Notification Details

Device IDK955300
510k NumberK955300
Device Name:TOTAL BILIRUBIN PROCEDURE
ClassificationDiazo Colorimetry, Bilirubin
Applicant DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
ContactC. H. Morris
CorrespondentC. H. Morris
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 Received1995-11-20
Decision Date1995-12-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00845275001068 K955300 000

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