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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Thrombin Time
510(k) Number K970645
Device Name BC THROMBIN REAGENT
Applicant
BEHRING DIAGNOSTICS, INC.
3403 YERBA BUENA RD.
P.O. BOX 49013
SAN JOSE,  CA  95161 -9013
Applicant Contact PAUL L ROGERS, JR.
Correspondent
BEHRING DIAGNOSTICS, INC.
3403 YERBA BUENA RD.
P.O. BOX 49013
SAN JOSE,  CA  95161 -9013
Correspondent Contact PAUL L ROGERS, JR.
Regulation Number864.7875
Classification Product Code
GJA  
Date Received02/20/1997
Decision Date 05/19/1997
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
Recalls CDRH Recalls
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