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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 K890281
Device Name HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES
Applicant
Cambridge Bioscience Corp.
365 Plantation St.
Worcester,  MA  01605
Applicant Contact JACK CASSORLA
Correspondent
Cambridge Bioscience Corp.
365 Plantation St.
Worcester,  MA  01605
Correspondent Contact JACK CASSORLA
Regulation Number866.3830
Classification Product Code
LSR  
Date Received01/17/1989
Decision Date 03/15/1989
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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