Enzyme Immunoassay Anti-Sm/Rnp Antibody Test Kit

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K940588 ↗

FDA Product Code

LKO

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Enzyme Immunoassay Anti-Double Stranded DNA (Dsdna) Test Kit

  Class II

  FDA 510(k) K960091 Active Cleared 20 Mar 1996

• Enzyme Immunoassay Anti-Sci-70 Antibody Test Kit

  Class II

  FDA 510(k) K951798 Active Cleared 17 Jul 1995

• Diamedix Immunosimplicity Ana (Is-Ana) Screen Test System

  Class II

  FDA 510(k) K980337 Active Cleared 12 May 1998

• Anti-Ss-B/La Antibody Test

  Class II

  FDA 510(k) K932419 Active Cleared 5 Aug 1993

• Anti-Dsdna Antibody Test

  Class II

  FDA 510(k) K913041 Active Cleared 5 Nov 1991

• Enzyme Immunoassay Anti-SS-A/Ro Antibody Test Kit

  Class II

  FDA 510(k) K931495 Active Cleared 16 Jul 1993

See all devices from Helix Diagnostics, Inc. →