ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL

Electrode, Ion Specific, Sodium

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Ion 4 Sodium/potassium/chloride/total.

Pre-market Notification Details

Device IDK842025
510k NumberK842025
Device Name:ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL
ClassificationElectrode, Ion Specific, Sodium
Applicant HI CHEM, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJGS  
CFR Regulation Number862.1665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-18
Decision Date1984-06-22

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