CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION— 510(k) K911578

Name: FDA 510(k) clearance K911578
Creator: U.S. Food and Drug Administration
Published: 1991-05-15

Substantially Equivalent

Cholestech Corp.

FDA 510(k) clearance K911578 for CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION, Substantially Equivalent on 1991-05-15. Applicant: Cholestech Corp.. Device class: 1.

Clearance details

Applicant: Cholestech Corp.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1991-03-27
Decision date: 1991-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHH

view all

K251091 — Lipids2025-12-30
K232404 — CHOLESTEROL; HDL-cholesterol; LDL-cholesterol; TRIGLYCERIDES2024-08-09
K203597 — Cholesterol22022-06-30
K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides2019-03-27
K181373 — Extended Lipid Panel Assay2018-10-18

More clearances from Cholestech Corp.

view all

K040579 — CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)2004-06-18
K032027 — CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)2003-09-05
K991834 — CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-7721999-09-09
K972012 — CHOLESTECH BUN/CREATININE TEST SYSTEM1997-07-24
K954778 — CHOLESTECH LDX SYSTEM1995-11-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.