CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)— 510(k) K040579

Clearance details

Applicant

Cholestech Corp.

Product code

Code DCK

Device class

Class 2

Regulation

21 CFR 866.5270

Advisory panel

Immunology

Date received

2004-03-04

Decision date

2004-06-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hayward, CA, US

• K242170 — K-ASSAY CRP (Ver.2)2025-04-18
• K201256 — Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge2022-11-04
• K192028 — Yumizen C1200 CRP2020-06-25
• K192118 — CRP Vario2019-11-08
• K191993 — Yumizen C1200 CRP2019-10-03

• 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
• K946063 — TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL1995-02-22

• Z-1178-2013 — The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum.Class II·Terminated·Alere San Diego, Inc.·20130306

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040579.