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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Factor Deficient
510(k) Number K895503
Device Name ABNORMAL REFERENCE PLASMA-VIII
Applicant
Medical Diagnostic Technologies, Inc.
6020 Nicolle St., Suite D
Ventura,  CA  93003
Applicant Contact BICK, PHD
Correspondent
Medical Diagnostic Technologies, Inc.
6020 Nicolle St., Suite D
Ventura,  CA  93003
Correspondent Contact BICK, PHD
Regulation Number864.7290
Classification Product Code
GJT  
Date Received09/12/1989
Decision Date 10/06/1989
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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