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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 K900400
Device Name ORTHOKROME* ANTITHROMBIN
Applicant
Ortho Diagnostic Systems, Inc.
1001 U.S. Hwy. 202
P.O Box 350
Raritan,  NJ  08869
Applicant Contact GAIL KROMER
Correspondent
Ortho Diagnostic Systems, Inc.
1001 U.S. Hwy. 202
P.O Box 350
Raritan,  NJ  08869
Correspondent Contact GAIL KROMER
Regulation Number864.7060
Classification Product Code
JBQ  
Date Received01/29/1990
Decision Date 03/15/1990
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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