Homogeneous Enzymic Homocysteine Reagent

• • Terminated Z-0448-2009 FDA Unclassified (pre-2012) ·initiated 18 Jan 2007

  A high homocysteine level can be reported as falsely low.

510(k) Number

K011692 ↗

FDA Product Code

LPS

Device Class

Class II

Regulation

21 CFR Part 862.1377

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Glucose Oxidase Reagent

  Class II

  FDA 510(k) K870616 Active Cleared 6 Mar 1987

• Intersect Systems Direct Amylase Reagent

  Class II

  FDA 510(k) K932888 Active Cleared 31 Jan 1994

• Intersect Systems Triglyceride-Gpo Reagent

  Class I

  FDA 510(k) K870827 Active Cleared 13 Mar 1987

• Enzymatic CO2 Reagent, Modification

  Class II

  FDA 510(k) K932267 Active Cleared 24 Sep 1993

• Carbon Dioxide Reagent

  Class II

  FDA 510(k) K881169 Active Cleared 28 Apr 1988

• Mini-Pecg

  Class II

  FDA 510(k) K832883 Active Cleared 6 Dec 1983

See all devices from Intersect Systems, Inc. →