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510(k) K003754

IMMUNETICS C6 LYME ELISA KIT by Immunetics, Inc. — Product Code LSR

K003754 is an FDA 510(k) premarket notification submitted by Immunetics, Inc. for the device "IMMUNETICS C6 LYME ELISA KIT". The FDA issued a decision of Substantially Equivalent on May 10, 2001. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Immunetics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2001
Date Received
December 5, 2000
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 Immunetics, Inc.

  • K040407 — QUICKELISA ANTHRAX-PA KIT (June 3, 2004)
  • K991062 — QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024 (September 21, 1999)
  • K991063 — QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024 (September 21, 1999)

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)
  • K203292 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (March 22, 2021)
  • K203289 — Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC 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)

FDA data resources