CALCIUM ASSAY KIT

Cresolphthalein Complexone, Calcium

DIAGNOSTIC CHEMICALS, LTD. (USA)

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

Pre-market Notification Details

Device IDK842509
510k NumberK842509
Device Name:CALCIUM ASSAY KIT
ClassificationCresolphthalein Complexone, Calcium
Applicant DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT CHARLOTTETOWN Canada, 
Product CodeCIC  
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-06-26
Decision Date1984-07-20

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