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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 K952515
Device Name COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY
Applicant
Chromogenix AB
160 Industrial Dr.
Franklin,  OH  45005
Applicant Contact CYNTHIA A IPACH
Correspondent
Chromogenix AB
160 Industrial Dr.
Franklin,  OH  45005
Correspondent Contact CYNTHIA A IPACH
Regulation Number864.7060
Classification Product Code
JBQ  
Date Received05/31/1995
Decision Date 01/23/1996
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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