FDA 510(k), K894224, MARDX LYME DISEASE EIA (IGG) TEST SYSTEM

FDA 510(k), K894224, MARDX LYME DISEASE EIA (IGG) TEST SYSTEM

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510(K) Number: K894224
Device Name: MARDX LYME DISEASE EIA (IGG) TEST SYSTEM
Manufacturer: MARDX DIAGNOSTICS, INC.
Device Classification Name: reagent, borrelia serological reagent
Regulation Number: 866.3830
Classification Product Code: LSR
Date Received: 06/19/1989
Decision Date: 08/21/1989
Regulation Medical Specialty: Microbiology

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