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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
Recalls CDRH Recalls
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