KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT

Ferrozine (colorimetric) Iron Binding Capacity

KING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for King Diagnostics Iron And Total Iron Binding Capacity Reagent.

Pre-market Notification Details

Device IDK933329
510k NumberK933329
Device Name:KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT
ClassificationFerrozine (colorimetric) Iron Binding Capacity
Applicant KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis,  IN  46220
ContactFrances Loh
CorrespondentFrances Loh
KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis,  IN  46220
Product CodeJMO  
CFR Regulation Number862.1415 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-08
Decision Date1993-10-22

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