SODIUM & POTASSIUM TEST KIT

Flame Photometry, Potassium

MALLINCKRODT CRITICAL CARE

The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Sodium & Potassium Test Kit.

Pre-market Notification Details

Device IDK810253
510k NumberK810253
Device Name:SODIUM & POTASSIUM TEST KIT
ClassificationFlame Photometry, Potassium
Applicant MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJGM  
CFR Regulation Number862.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-01-30
Decision Date1981-02-10

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