FERRO-QUANT TM FE 59 TEST KIT

Radiometric, Fe59, Iron Binding Capacity

MALLINCKRODT CRITICAL CARE

The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Ferro-quant Tm Fe 59 Test Kit.

Pre-market Notification Details

Device IDK800868
510k NumberK800868
Device Name:FERRO-QUANT TM FE 59 TEST KIT
ClassificationRadiometric, Fe59, Iron Binding Capacity
Applicant MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJQG  
CFR Regulation Number862.1415 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-17
Decision Date1980-04-29

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