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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, Potassium
510(k) Number K830104
Device Name SERUM IRON DIAGNOSTIC TEST KITS
Applicant
Sclavo, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sclavo, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1600
Classification Product Code
CEM  
Date Received01/11/1983
Decision Date 01/28/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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