FDA 510(k), K950829, MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM

FDA 510(k), K950829, MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM

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510(K) Number: K950829
Device Name: MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
Manufacturer: MARDX DIAGNOSTICS, INC.
Device Classification Name: reagent, borrelia serological reagent
Regulation Number: 866.3830
Classification Product Code: LSR
Date Received: 02/23/1995
Decision Date: 06/05/1996
Regulation Medical Specialty: Microbiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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