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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Antiserum, Control, Antithrombin Iii
510(k) Number K935307
Device Name DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA
Applicant
Baxter Diagnostics, Inc.
P.O.Box 520672
Miami,  FL  33152
Applicant Contact RADAMES RIESGO
Correspondent
Baxter Diagnostics, Inc.
P.O.Box 520672
Miami,  FL  33152
Correspondent Contact RADAMES RIESGO
Regulation Number864.7060
Classification Product Code
DDQ  
Date Received11/02/1993
Decision Date 11/22/1994
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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