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510(k) K983606

IS BORRELIA BURGDORFERI IGM TEST SYSTEM by Columbia Bioscience, Inc. — Product Code LSR

K983606 is an FDA 510(k) premarket notification submitted by Columbia Bioscience, Inc. for the device "IS BORRELIA BURGDORFERI IGM TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on December 16, 1998. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Columbia Bioscience, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1998
Date Received
October 14, 1998
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 Columbia Bioscience, Inc.

  • K990462 — IS H. PYLORI IGG ELISA TEST SYSTEM (September 3, 1999)
  • K991274 — MUMPS IGG ELISA TEST SYSTEM (September 3, 1999)
  • K984228 — IS ANTI-TPO IGG ELISA TEST SYSTEM (February 2, 1999)
  • K983605 — IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (December 16, 1998)
  • K983553 — ANTI-TG IGG ELISA TEST SYSTEM (December 7, 1998)
  • K982352 — VCA IGM ELISA TEST SYSTEM (November 25, 1998)
  • K982348 — EBNA-1 IGM ELISA TEST SYSTEM (November 25, 1998)
  • K982350 — EA-D IGM ELISA TEST SYSTEM (November 25, 1998)
  • K983390 — IS-ANTI-MPO IGG ELISA TEST SYSTEM (November 18, 1998)
  • K983740 — IS-ANTI-PR3 IGG ELISA TEST SYSTEM (November 18, 1998)

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)
  • 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)

FDA data resources