TOTAL BILIRUBIN

Diazo Colorimetry, Bilirubin

JAS Diagnostics, Inc.

The following data is part of a premarket notification filed by Jas Diagnostics, Inc. with the FDA for Total Bilirubin.

Pre-market Notification Details

Device IDK003829
510k NumberK003829
Device Name:TOTAL BILIRUBIN
ClassificationDiazo Colorimetry, Bilirubin
Applicant JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami,  FL  33166
ContactDavid Johnston
CorrespondentDavid Johnston
JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami,  FL  33166
Product CodeCIG  
CFR Regulation Number862.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-11
Decision Date2001-02-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817274022528 K003829 000
00817274021989 K003829 000
00817274021972 K003829 000
00817274021965 K003829 000
00817274021958 K003829 000
00817274021941 K003829 000

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