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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Sodium
510(k) Number K843452
Device Name STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ
Applicant
Fisher Scientific Co., LLC
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Fisher Scientific Co., LLC
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1665
Classification Product Code
JGS  
Date Received09/05/1984
Decision Date 09/27/1984
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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