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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K862537
Device Name KOAGULAB* M COAGULATION SYSTEM
Applicant
ORTHO DIAGNOSTIC SYSTEMS, INC.
1001 U.S. HIGHWAY 202
P.O. BOX 350
RARITAN,  NJ  08869 -0606
Applicant Contact PATRICIA BONNESS
Correspondent
ORTHO DIAGNOSTIC SYSTEMS, INC.
1001 U.S. HIGHWAY 202
P.O. BOX 350
RARITAN,  NJ  08869 -0606
Correspondent Contact PATRICIA BONNESS
Regulation Number864.5425
Classification Product Code
JPA  
Date Received07/02/1986
Decision Date 07/21/1986
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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