FDA 510(k), K911590, IMMUNOWELL BORRELIA (LYME)TEST

FDA 510(k), K911590, IMMUNOWELL BORRELIA (LYME)TEST

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510(K) Number: K911590
Device Name: IMMUNOWELL BORRELIA (LYME)TEST
Manufacturer: GENERAL BIOMETRICS, INC.
Device Classification Name: reagent, borrelia serological reagent
Regulation Number: 866.3830
Classification Product Code: LSR
Date Received: 04/09/1991
Decision Date: 12/20/1991
Regulation Medical Specialty: Microbiology

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