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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Fibrinogen Determination
510(k) Number K922416
Device Name FIBRINOGEN RID 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 Number864.7340
Classification Product Code
KQJ  
Date Received05/21/1992
Decision Date 03/09/1993
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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