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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K013492
Device Name IMUBIND TPA ELISA, MODEL 860
Applicant
American Diagnostica, Inc.
222 Railroad Ave.
Greenwich,  CT  06830
Applicant Contact JOHN B BERRYMAN
Correspondent
American Diagnostica, Inc.
222 Railroad Ave.
Greenwich,  CT  06830
Correspondent Contact JOHN B BERRYMAN
Regulation Number864.7290
Classification Product Code
GGP  
Date Received10/22/2001
Decision Date 03/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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