Cholesterol Asssay Kit

• • Terminated Z-0711-2011 FDA Unclassified (pre-2012) ·initiated 10 Nov 2010

  Cholesterol Reagent bottles labels reversed for R1 and R2

510(k) Number

K842160 ↗

FDA Product Code

CHH

Device Class

Class I

Regulation

21 CFR Part 862.1175

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Calcium, Catalogue Number 122-20

  Class II

  FDA 510(k) K881054 Active Cleared 18 Apr 1988

• Vma Assay Kit

  Class I

  FDA 510(k) K843379 Active Cleared 28 Sep 1984

• Aspartate Aminotransferase Assay Kit (Ifcc)

  Class II

  FDA 510(k) K880692 Active Cleared 27 May 1988

• Acid Phosphatase (Kinetic) Cat. # 320-06

  Class II

  FDA 510(k) K875209 Active Cleared 1 Feb 1988

• Serum Iron & Serum Iron Binding Capacity

  Class I

  FDA 510(k) K842156 Active Cleared 7 Aug 1984

• Chloride Cat. # 152-17

  Class II

  FDA 510(k) K875208 Active Cleared 18 Apr 1988

See all devices from Diagnostic Chemicals, Ltd. (Usa) →