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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 K971170
Device Name CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)
Applicant
Cambridge Biotech Corp.
1500 E. Gude Dr.
Rockville,  MD  20850 -5307
Applicant Contact REBECCA LEAPER
Correspondent
Cambridge Biotech Corp.
1500 E. Gude Dr.
Rockville,  MD  20850 -5307
Correspondent Contact REBECCA LEAPER
Regulation Number866.3830
Classification Product Code
LSR  
Date Received03/28/1997
Decision Date 02/17/1998
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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