Bartels Lyme Disease Igm Eia

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K922578 ↗

FDA Product Code

LSR

Device Class

Class II

Regulation

21 CFR Part 866.3830

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Dade(R) Myoglobin Controls Tri-Level

  Class II

  FDA 510(k) K922387 Active Cleared 15 Jul 1992

• Bartels Prima System Advanced Screening Cartridge

  Class I

  FDA 510(k) K914202 Active Cleared 11 Oct 1991

• Bartels Herpes Simplex Virus 2 Igg Eia

  Class II

  FDA 510(k) K922583 Active Cleared 28 Sep 1992

• Dried Gram-Negative Mic/Combo Panels

  Class II

  FDA 510(k) K932082 Active Cleared 20 Jul 1993

• Paramax(R) Phenytoin Reagent

  Class II

  FDA 510(k) K932686 Active Cleared 26 Nov 1993

• Dried Gram Negative/Cefmetazole

  Class II

  FDA 510(k) K941317 Active Cleared 31 Jan 1995

See all devices from Baxter Diagnostics, Inc. →