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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibody Igm, If, Epstein-Barr Virus
510(k) Number K915348
Device Name EBV-VCA IGM ELISA
Applicant
Pharmacia Diagnostics, Inc.
9033 Red Branch Rd.
Columbia,  MD  21045
Applicant Contact STEVEN VINSON
Correspondent
Pharmacia Diagnostics, Inc.
9033 Red Branch Rd.
Columbia,  MD  21045
Correspondent Contact STEVEN VINSON
Regulation Number866.3235
Classification Product Code
LJN  
Date Received11/26/1991
Decision Date 02/14/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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