High Density Lipoprotein Cholesterol

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K912823 ↗

FDA Product Code

LBR

Device Class

Class I

Regulation

21 CFR Part 862.1475

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Clp Ck/Ld Isoenzyme/Immuno Control

  Class I

  FDA 510(k) K896465 Active Cleared 1 Mar 1990

• Clp Abnormal Coagulation Control

  Class II

  FDA 510(k) K881510 Active Cleared 6 May 1988

• Total Iron and Unsat Iron Bind Capac/Iron Bind Cal

  Class II

  FDA 510(k) K913371 Active Cleared 8 Nov 1991

• Clp High Level High Density Lipo Protein Cholesterol Control-Hl

  Class I

  FDA 510(k) K950589 Active Cleared 20 Mar 1995

• Clp Normal Lipid Control

  Class I

  FDA 510(k) K895862 Active Cleared 19 Jan 1990

• Clp Ck/Ld Isoenzyme Control

  Class I

  FDA 510(k) K894554 Active Cleared 16 Oct 1989

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