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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: LSR Applicant: GENERAL BIOMETRICS, INC. Decision Date To: 05/06/2024
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immunodot borrelia (lyme) test GENERAL BIOMETRICS, INC. K911627 04/08/1992
immunowell lyme (p39 recombinant) test GENERAL BIOMETRICS, INC. K911599 12/30/1991
immunowell borrelia (lyme)test GENERAL BIOMETRICS, INC. K911590 12/20/1991
immunodot lyme test GENERAL BIOMETRICS, INC. K894410 10/30/1989
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