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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 K950829
Device Name MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
Applicant
Mardx Diagnostics, Inc.
5919 Farnsworth Ct.
Carlsbad,  CA  92008
Applicant Contact ARTHUR MARKOVITS
Correspondent
Mardx Diagnostics, Inc.
5919 Farnsworth Ct.
Carlsbad,  CA  92008
Correspondent Contact ARTHUR MARKOVITS
Regulation Number866.3830
Classification Product Code
LSR  
Date Received02/23/1995
Decision Date 06/05/1996
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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