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510(k) K950829

MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM by Mardx Diagnostics, Inc. — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1996
Date Received
February 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Borrelia Serological Reagent
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

Other clearances by Mardx Diagnostics, Inc.

  • K964787 — MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM (April 8, 1997)
  • K951709 — MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM (June 7, 1996)
  • K960182 — DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM (March 20, 1996)
  • K894224 — MARDX LYME DISEASE EIA (IGG) TEST SYSTEM (August 21, 1989)
  • K894293 — MARDX LYME DISEASE EIA (IGM) TEST SYSTEM (August 21, 1989)
  • K892206 — MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM (August 15, 1989)
  • K890053 — MARDX LYME DISEASE IGG IFA TEST SYSTEM (April 18, 1989)

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