BILIRUBIN ASSAY KIT - TOTAL

Diazo Colorimetry, Bilirubin

DIAGNOSTIC CHEMICALS, LTD. (USA)

The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Bilirubin Assay Kit - Total.

Pre-market Notification Details

Device IDK843032
510k NumberK843032
Device Name:BILIRUBIN ASSAY KIT - TOTAL
ClassificationDiazo Colorimetry, Bilirubin
Applicant DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT CHARLOTTETOWN Canada, 
Product CodeCIG  
CFR Regulation Number862.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-08-01
Decision Date1984-09-04

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