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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antithrombin Iii Quantitation
510(k) Number K913667
Device Name ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT
Applicant
The Binding Site, Ltd.
Westside Towers, Suite 1000
11845 W. Olympic Blvd.
Los Angeles,  CA  90064
Applicant Contact JAY H GELLER
Correspondent
The Binding Site, Ltd.
Westside Towers, Suite 1000
11845 W. Olympic Blvd.
Los Angeles,  CA  90064
Correspondent Contact JAY H GELLER
Regulation Number864.7060
Classification Product Code
JBQ  
Date Received08/19/1991
Decision Date 01/03/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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