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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 K911590
Device Name IMMUNOWELL BORRELIA (LYME)TEST
Applicant
GENERAL BIOMETRICS, INC.
15222 Avenue of Science
Suite A
San DIego,  CA  92128
Applicant Contact BRYAN L KIEHL
Correspondent
GENERAL BIOMETRICS, INC.
15222 Avenue of Science
Suite A
San DIego,  CA  92128
Correspondent Contact BRYAN L KIEHL
Regulation Number866.3830
Classification Product Code
LSR  
Date Received04/09/1991
Decision Date 12/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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