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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 K931420
Device Name COATEST(R) ANTITHROMBIN III, MODIFICATION
Applicant
Kabi Pharmacia Hepar, Inc.
160 Industrial Dr.
Franklin,  OH  45005
Applicant Contact MADELEINE BURMESTER
Correspondent
Kabi Pharmacia Hepar, Inc.
160 Industrial Dr.
Franklin,  OH  45005
Correspondent Contact MADELEINE BURMESTER
Regulation Number864.7060
Classification Product Code
JBQ  
Date Received03/09/1993
Decision Date 05/02/1994
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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