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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 K911496
Device Name FASTTECH SYSTEM 1
Applicant
3M Diagnostic Systems, Inc.
3380 Central Expy.
Santa Clara,  CA  95051
Applicant Contact SYLVIA ZORICH
Correspondent
3M Diagnostic Systems, Inc.
3380 Central Expy.
Santa Clara,  CA  95051
Correspondent Contact SYLVIA ZORICH
Regulation Number866.3830
Classification Product Code
LSR  
Date Received04/04/1991
Decision Date 06/24/1991
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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