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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 K800216
Device Name SODIUM/POTASSIUM CONDITIONING REAGENT
Applicant
Fisher Scientific Co., LLC
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Fisher Scientific Co., LLC
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1665
Classification Product Code
JGS  
Date Received02/04/1980
Decision Date 02/26/1980
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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