SODIUM/POTASSIUM BUFFER SOLUTION

Electrode, Ion Specific, Potassium

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Sodium/potassium Buffer Solution.

Pre-market Notification Details

Device IDK791692
510k NumberK791692
Device Name:SODIUM/POTASSIUM BUFFER SOLUTION
ClassificationElectrode, Ion Specific, Potassium
Applicant HI CHEM, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCEM  
CFR Regulation Number862.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-07-31
Decision Date1979-09-17

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