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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 K934351
Device Name APTT-ES REAGENT
Applicant
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
6025 NICOLLE ST.
VENTURA,  CA  93003
Applicant Contact MICHAEL D BICK
Correspondent
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
6025 NICOLLE ST.
VENTURA,  CA  93003
Correspondent Contact MICHAEL D BICK
Regulation Number864.7925
Classification Product Code
GFO  
Date Received09/07/1993
Decision Date 12/06/1993
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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