Mas Liquid Urinalysis Control Level 1, Level 2 and Level 3

• • Terminated Z-0383-2014 FDA Class III ·initiated 29 Oct 2013

  Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day open vial stability specifications for Lot: UA1514011.

510(k) Number

K973451 ↗

FDA Product Code

JJW

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. →