Reagent a and Reagent B

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K874413 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Qms Quinidine. Qms Quinidine Calibrators

  Class II

  FDA 510(k) K052826 Active Cleared 23 Dec 2005

• Qms / Multigent Valproic Acid Reagent, Part #396075

  Class II

  FDA 510(k) K030405 Active Cleared 28 Apr 2003

• Lpia-Ferritin Assay

  Class I

  FDA 510(k) K924186 Active Cleared 23 Dec 1992

• Qms Lamotrigine Assay (Reagents), Calibrators & Controls

  Class II

  FDA 510(k) K062966 Active Cleared 12 Jan 2007

• Qms - Digoxin

  Class II

  FDA 510(k) K913562 Active Cleared 30 Aug 1991

• Qms(Tm) - Theophylline

  Class I

  FDA 510(k) K885263 Active Cleared 28 Mar 1989

See all devices from Seradyn, Inc. →