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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tetraphenyl borate, colorimetry, potassium
510(k) Number K832553
Device Name POTASSIUM TEST KIT
Applicant
MALLINCKRODT CRITICAL CARE
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MALLINCKRODT CRITICAL CARE
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1600
Classification Product Code
CEJ  
Date Received08/01/1983
Decision Date 09/20/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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