BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02

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 (direct), Cata. Number 202-02.

Pre-market Notification Details

Device IDK861094
510k NumberK861094
Device Name:BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02
ClassificationDiazo Colorimetry, Bilirubin
Applicant DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada,  CA C1e 1b0
ContactCallbeck, R.t.
CorrespondentCallbeck, R.t.
DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada,  CA C1e 1b0
Product CodeCIG  
CFR Regulation Number862.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-24
Decision Date1986-04-21

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