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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer
510(k) Number K072901
Device Name AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101
Applicant
Amdl, Inc.
2492 Walnut Ave. Suite 100
Tustin,  CA  92780 -7039
Applicant Contact GARY DREHER
Correspondent
Amdl, Inc.
2492 Walnut Ave. Suite 100
Tustin,  CA  92780 -7039
Correspondent Contact GARY DREHER
Regulation Number866.6010
Classification Product Code
NTY  
Date Received10/11/2007
Decision Date 07/01/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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