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510(k) K904652

LYME STAT M TEST KIT by Whittaker Bioproducts, Inc. — Product Code LSR

K904652 is an FDA 510(k) premarket notification submitted by Whittaker Bioproducts, Inc. for the device "LYME STAT M TEST KIT". The FDA issued a decision of Substantially Equivalent on October 21, 1991. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Whittaker Bioproducts, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1991
Date Received
October 15, 1990
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 Whittaker Bioproducts, Inc.

  • K911356 — LEGIONELLA STAT IGG/IGM TEST KIT (July 30, 1992)
  • K913212 — 3M IGE SINGLE POINT FAST TEST (November 22, 1991)
  • K904893 — FIAX LYME M TEST KIT (October 16, 1991)
  • K911473 — EBNA STAT TEST KIT (September 25, 1991)
  • K904738 — PYLORI STAT TEST KIT (May 7, 1991)
  • K905468 — PYLORI-G FIAX TEST KIT (May 7, 1991)
  • K901493 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B (June 27, 1990)
  • K893579 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A (January 16, 1990)
  • K894932 — FIAX EB VCA-M TEST KIT (October 16, 1989)
  • K894235 — EB VCA STAT M TEST KIT (August 30, 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)
  • 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