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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 K924637
Device Name HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT
Applicant
INTERNATIONAL TECHNIDYNE CORP.
23 NEVSKY ST.
EDISON,  NJ  08820
Applicant Contact MATT LESNIESKI
Correspondent
INTERNATIONAL TECHNIDYNE CORP.
23 NEVSKY ST.
EDISON,  NJ  08820
Correspondent Contact MATT LESNIESKI
Regulation Number864.7925
Classification Product Code
GFO  
Date Received09/01/1992
Decision Date 01/27/1993
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
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