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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flame Photometry, Potassium
510(k) Number K810253
Device Name SODIUM & 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
JGM  
Date Received01/30/1981
Decision Date 02/10/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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