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510(k) K894293

MARDX LYME DISEASE EIA (IGM) TEST SYSTEM by Mardx Diagnostics, Inc. — Product Code LSR

K894293 is an FDA 510(k) premarket notification submitted by Mardx Diagnostics, Inc. for the device "MARDX LYME DISEASE EIA (IGM) TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on August 21, 1989. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Mardx Diagnostics, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1989
Date Received
June 23, 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)
  • K892206 — MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM (August 15, 1989)
  • K890053 — MARDX LYME DISEASE IGG IFA TEST SYSTEM (April 18, 1989)

Other clearances for product code LSR

  • K254295 — Sofia Lyme FIA; Sofia 2 Campylobacter FIA (July 10, 2026)
  • 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)
  • 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)
  • K203295 — Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (March 22, 2021)
  • K203296 — Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (March 22, 2021)

FDA data resources