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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Borrelia Serological Reagent
510(k) Number K943812
Device Name VIDAS LYME SCREEN II
Applicant
Biomerieux Vitek, Inc.
1022 Hingham St.
Rockland,  MA  02370
Applicant Contact TERRY MCGOVERN
Correspondent
Biomerieux Vitek, Inc.
1022 Hingham St.
Rockland,  MA  02370
Correspondent Contact TERRY MCGOVERN
Regulation Number866.3830
Classification Product Code
LSR  
Date Received08/05/1994
Decision Date 06/13/1995
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
Recalls CDRH Recalls
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