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510(k) K965129

BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM by Wampole Laboratories — Product Code LSR

K965129 is an FDA 510(k) premarket notification submitted by Wampole Laboratories for the device "BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on March 26, 1997. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Wampole Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1997
Date Received
December 23, 1996
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 Wampole Laboratories

  • K965131 — BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (March 26, 1997)
  • K911444 — RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM (August 30, 1991)
  • K882896 — ONE-STEP HCG (October 31, 1988)
  • K883004 — MONO-PLUS(TM) (August 4, 1988)
  • K875101 — VIROGEN CMV ANTIBODY TEST (March 1, 1988)
  • K875161 — MAT (TM) MICROALBUMIN TEST (February 17, 1988)
  • K791309 — UCG-LYPHOTEST (July 30, 1979)
  • K790986 — RF CONTROLS (June 28, 1979)
  • K781794 — BETA-TEC (December 29, 1978)
  • K760336 — BIOCEPT-G (November 12, 1976)

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