Mas Cardioimmune Tl Low Level Liquid Assayed Cardiac Marker Control, Dade Cardiac Tl Low Level Liquid Assayed Cardiac Ma

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K023669 ↗

FDA Product Code

JJY

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Dade Assayed Urinalysis Control

  Class I

  FDA 510(k) K023928 Active Cleared 11 Dec 2002

• Amylase Sr Liquid Stable Reagent Set

  Class II

  FDA 510(k) K862733 Active Cleared 29 Sep 1986

• Mas Lipid Level 1 and 2

  Class I

  FDA 510(k) K030679 Active Cleared 14 Mar 2003

• Tdcontrol Liquid Multi-Analyte Therapeutic Drug

  Class I

  FDA 510(k) K870586 Active Cleared 1 Apr 1987

• Challenge (Tm) Liq Thera Drug Controls

  Class I

  FDA 510(k) K910333 Active Cleared 12 Apr 1991

• Reflab System Pack Liquid Fructosamine Reagent

  Class II

  FDA 510(k) K920397 Active Cleared 4 Aug 1992

See all devices from Medical Analysis Systems, Inc. →