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510(k) K911599

IMMUNOWELL LYME (P39 RECOMBINANT) TEST by General Biometrics, Inc. — Product Code LSR

K911599 is an FDA 510(k) premarket notification submitted by General Biometrics, Inc. for the device "IMMUNOWELL LYME (P39 RECOMBINANT) TEST". The FDA issued a decision of Substantially Equivalent on December 30, 1991. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. General Biometrics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1991
Date Received
April 9, 1991
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 General Biometrics, Inc.

  • K924843 — IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL (December 1, 1992)
  • K920400 — IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST (August 20, 1992)
  • K920401 — IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST (August 20, 1992)
  • K911627 — IMMUNODOT BORRELIA (LYME) TEST (April 8, 1992)
  • K911590 — IMMUNOWELL BORRELIA (LYME)TEST (December 20, 1991)
  • K914801 — IMMUNOWELL DSDNA ANTIBODY TEST (December 9, 1991)
  • K911851 — IMMUNOWELL SM ANTIBODY TEST (May 7, 1991)
  • K911849 — IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST (May 7, 1991)
  • K911850 — IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST (May 7, 1991)
  • K911848 — IMMUNOWELL RNP/SM ANTIBODY TEST (May 7, 1991)

Other clearances for product code LSR

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  • 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