Rheuma-Lex(Tm) Syst: Rheumatoid Factor Latex Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K915320 ↗

FDA Product Code

DHR

Device Class

Class II

Regulation

21 CFR Part 866.5775

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Disposable Skin Staple Remover

  Class I

  FDA 510(k) K920283 Active Cleared 22 May 1992

• Minor Laceration Tray W/ Instrument, Sterile, Disp

  Class II

  FDA 510(k) K920517 Active Cleared 11 May 1992

• Sterile Water

  Class II

  FDA 510(k) K933526 Active Cleared 10 Mar 1994

• Tracheostomy Care Kit

  Class II

  FDA 510(k) K921281 Active Cleared 27 Aug 1992

• Mono-Lex System: Infectious Mononucleosis Latex

  Class II

  FDA 510(k) K902541 Active Cleared 28 Jun 1990

• Continuous Epidural Anesthesia Tray

  Class II

  FDA 510(k) K945671 Active Cleared 16 Feb 1995

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