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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catalytic Methods, Amylase
510(k) Number K873133
Device Name BNP-AMYLASE TEST
Applicant
Sclavo, Inc.
5 Mansard Court
Wayne,  NJ  07470
Applicant Contact DEBRA HOFMEISTER
Correspondent
Sclavo, Inc.
5 Mansard Court
Wayne,  NJ  07470
Correspondent Contact DEBRA HOFMEISTER
Regulation Number862.1070
Classification Product Code
JFJ  
Date Received08/10/1987
Decision Date 10/06/1987
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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