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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 K895713
Device Name 3M IGG FASTLYME(TM) TEST
Applicant
3M Company
3380 Central Expy.
Santa Clara,  CA  95051
Applicant Contact SYLVIA ZORICH
Correspondent
3M Company
3380 Central Expy.
Santa Clara,  CA  95051
Correspondent Contact SYLVIA ZORICH
Regulation Number866.3830
Classification Product Code
LSR  
Date Received09/25/1989
Decision Date 12/14/1990
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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