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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antithrombin Iii Quantitation
510(k) Number K936196
Device Name ANTITHROMBIN III CHROMOGENIC ASSAY
Applicant
BAXTER DIAGNOSTICS, INC.
1851 DELAWARE PKWY.
MIAMI,  FL  33125
Applicant Contact RONALD H LENTSCH, PH.D
Correspondent
BAXTER DIAGNOSTICS, INC.
1851 DELAWARE PKWY.
MIAMI,  FL  33125
Correspondent Contact RONALD H LENTSCH, PH.D
Regulation Number864.7060
Classification Product Code
JBQ  
Date Received12/29/1993
Decision Date 05/04/1994
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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