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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 K883544
Device Name LYME FAST TEST
Applicant
3M Company
3380 Central Expy.
Santa Clara,  CA  95051
Applicant Contact MONTE
Correspondent
3M Company
3380 Central Expy.
Santa Clara,  CA  95051
Correspondent Contact MONTE
Regulation Number866.3830
Classification Product Code
LSR  
Date Received08/19/1988
Decision Date 01/13/1989
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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