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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
510(k) Number K884649
Device Name TOTAL IRON BINDING CAPACITY TEST
Applicant
Sclavo, Inc.
5 Mansard Ct.
Wayne,  NJ  07470
Applicant Contact KING, PH.D.
Correspondent
Sclavo, Inc.
5 Mansard Ct.
Wayne,  NJ  07470
Correspondent Contact KING, PH.D.
Regulation Number862.1415
Classification Product Code
JQE  
Date Received11/07/1988
Decision Date 12/14/1988
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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