Cholesterol

• • Terminated Z-0404-03 FDA Unclassified (pre-2012) ·initiated 7 Nov 2002

  Potential for reporting lower than actual HDL (cholesterol) results due to low QC Recovery

510(k) Number

K880237 ↗

FDA Product Code

CHH

Device Class

Class I

Regulation

21 CFR Part 862.1175

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Alt (Sgpt) Reagent Set

  Class I

  FDA 510(k) K880275 Active Cleared 1 Mar 1988

• Creatine Kinase (Ck) Reagent Set

  Class II

  FDA 510(k) K881237 Active Cleared 28 Apr 1988

• Glucose Hexokinase

  Class II

  FDA 510(k) K880236 Active Cleared 15 Mar 1988

• Triglyceride

  Class I

  FDA 510(k) K880238 Active Cleared 15 Mar 1988

• Urea Nitrogen (Bun)

  Class II

  FDA 510(k) K880078 Active Cleared 11 Feb 1988

• Magnesium Reagent Set

  Class I

  FDA 510(k) K882256 Active Cleared 8 Aug 1988

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