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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 K911599
Device Name IMMUNOWELL LYME (P39 RECOMBINANT) TEST
Original Applicant
GENERAL BIOMETRICS, INC.
15222 avenue of science
suite a
san diego,  CA  92128
Original Contact bryan l kiehl
Regulation Number866.3830
Classification Product Code
LSR  
Date Received04/09/1991
Decision Date 12/30/1991
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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