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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Epstein-Barr Virus, Other
510(k) Number K992191
Device Name ETI-EA-G ASSAY
Applicant
DIASORIN, INC.
9175 GUIFORD RD.
COLUMBIA,  MD  21046
Applicant Contact JUDITH J SMITH
Correspondent
TUV PRODUCT SERVICE, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact CAROLE STAMP
Regulation Number866.3235
Classification Product Code
LSE  
Date Received06/28/1999
Decision Date 07/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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