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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 K081362
Device Name PLATELIA LYME IGM
Applicant
Bio-Rad
163 Cabot St.
Beverly,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
Bio-Rad
163 Cabot St.
Beverly,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number866.3830
Classification Product Code
LSR  
Date Received05/15/2008
Decision Date 06/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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