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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K895943
Device Name NORMAL AND ABNORMAL CONTROL SERA
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 Number862.1660
Classification Product Code
JJY  
Date Received10/11/1989
Decision Date 12/27/1989
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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