SALICYLATE ASSAY KIT

Colorimetry, Salicylate

DIAGNOSTIC CHEMICALS, LTD. (USA)

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

Pre-market Notification Details

Device IDK842158
510k NumberK842158
Device Name:SALICYLATE ASSAY KIT
ClassificationColorimetry, Salicylate
Applicant DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT CHARLOTTETOWN Canada, 
ContactKaren Mcmahon
CorrespondentKaren Mcmahon
DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT CHARLOTTETOWN Canada, 
Product CodeDKJ  
CFR Regulation Number862.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-30
Decision Date1984-10-22

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