SERUM IRON & SERUM IRON BINDING CAPACI

Bathophenanthroline, Colorimetry, Iron (non-heme)

DIAGNOSTIC CHEMICALS, LTD. (USA)

The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Serum Iron & Serum Iron Binding Capaci.

Pre-market Notification Details

Device IDK842155
510k NumberK842155
Device Name:SERUM IRON & SERUM IRON BINDING CAPACI
ClassificationBathophenanthroline, Colorimetry, Iron (non-heme)
Applicant DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT CHARLOTTETOWN Canada, 
Product CodeCFM  
CFR Regulation Number862.1410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-30
Decision Date1984-08-07

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