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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 K991062
Device Name QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024
Applicant
Immunetics, Inc.
63 Rogers St.
Cambridge,,  MA  02142
Applicant Contact ANDREW E LEVIN
Correspondent
Immunetics, Inc.
63 Rogers St.
Cambridge,,  MA  02142
Correspondent Contact ANDREW E LEVIN
Regulation Number866.3830
Classification Product Code
LSR  
Date Received03/31/1999
Decision Date 09/21/1999
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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