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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
510(k) Number K870516
Device Name ALBUMIN SCREEN TEST
Applicant
Sclavo, Inc.
5 Mansard Ct.
Wayne,  NJ  07470
Applicant Contact DEBRA HOFMEISTER
Correspondent
Sclavo, Inc.
5 Mansard Ct.
Wayne,  NJ  07470
Correspondent Contact DEBRA HOFMEISTER
Regulation Number862.1645
Classification Product Code
JIQ  
Date Received02/04/1987
Decision Date 10/20/1987
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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