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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Control, Normal
510(k) Number K935254
Device Name DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA
Applicant
American Diagnostica, Inc.
222 Railroad Ave.
P.O. Box 1165
Greenwich,  CT  06836
Applicant Contact RICHARD HART
Correspondent
American Diagnostica, Inc.
222 Railroad Ave.
P.O. Box 1165
Greenwich,  CT  06836
Correspondent Contact RICHARD HART
Regulation Number864.5425
Classification Product Code
GIZ  
Subsequent Product Code
GGC  
Date Received11/01/1993
Decision Date 09/19/1994
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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