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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K925604
Device Name ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT
Applicant
ORTHO DIAGNOSTIC SYSTEMS, INC.
1001 U.S. HIGHWAY 202
P.O. BOX 350
RARITAN,  NJ  08869 -0606
Applicant Contact PATRICK A ROCHE
Correspondent
ORTHO DIAGNOSTIC SYSTEMS, INC.
1001 U.S. HIGHWAY 202
P.O. BOX 350
RARITAN,  NJ  08869 -0606
Correspondent Contact PATRICK A ROCHE
Regulation Number864.7750
Classification Product Code
GJS  
Date Received11/05/1992
Decision Date 03/12/1993
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
Recalls CDRH Recalls
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