Sm Eia Test Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K935414 ↗

FDA Product Code

LJM

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Rnp Eia Test Kit

  Class II

  FDA 510(k) K935415 Active Cleared 2 May 1994

• Scl-70 Eia Test Kit

  Class II

  FDA 510(k) K935418 Active Cleared 5 May 1994

• Ro Eia Test Kit

  Class II

  FDA 510(k) K935416 Active Cleared 2 May 1994

• Mitochondria Eia Test Kit

  Class II

  FDA 510(k) K940251 Active Cleared 3 May 1994

• Histone Eia Test Kit

  Class II

  FDA 510(k) K940253 Active Cleared 2 May 1994

• La Eia Test Kit

  Class II

  FDA 510(k) K935419 Active Cleared 5 May 1994

See all devices from David A. Fuccillo, Ph.D. →