Home / 510(k) Clearances / K890053

510(k) K890053

MARDX LYME DISEASE IGG IFA TEST SYSTEM by Mardx Diagnostics, Inc. — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1989
Date Received
January 6, 1989
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)
  • K950829 — MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM (June 5, 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)

Other clearances for product code LSR

  • K252627 — Lyme-ID IgG Test; Bio-ID800 (November 14, 2025)
  • K242872 — iDart Lyme IgM ImmunoBlot Kit (June 12, 2025)
  • K233367 — iDart Lyme IgG ImmunoBlot Kit (August 12, 2024)
  • K230863 — ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia Vl (July 13, 2023)
  • K220016 — Viramed Borrela All-In-One ViraChip Test Kit (August 19, 2022)
  • K203295 — Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (March 22, 2021)
  • K203289 — Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit (March 22, 2021)
  • K203292 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (March 22, 2021)
  • K203296 — Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (March 22, 2021)
  • K202573 — LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus (February 18, 2021)