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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Partial Thromboplastin
510(k) Number K955638
Device Name SYNTHAFAX APTT REAGENT
Applicant
ORTHO DIAGNOSTIC SYSTEMS, INC.
1001 U.S. HIGHWAY 202
P.O. BOX 350
RARITAN,  NJ  08869 -0606
Applicant Contact BLANCHE CHIEN
Correspondent
ORTHO DIAGNOSTIC SYSTEMS, INC.
1001 U.S. HIGHWAY 202
P.O. BOX 350
RARITAN,  NJ  08869 -0606
Correspondent Contact BLANCHE CHIEN
Regulation Number864.7925
Classification Product Code
GFO  
Subsequent Product Code
GGP  
Date Received12/11/1995
Decision Date 04/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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