Atlas FDA

CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)

FDA 510(k) clearance K040579 · decided 2004-06-18

Clearance details

K-number
K040579
Device name
CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
Applicant
Cholestech Corp.
Decision
Substantially Equivalent
Date received
2004-03-04
Decision date
2004-06-18
Days to decision
106 days
Clearance type
Traditional
Product code
DCK
Device class
2
Regulation number
866.5270
Medical specialty
Immunology
Advisory committee
Immunology
Location
Hayward, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Cholestech Corp.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
K-ASSAY CRP (Ver.2) (K242170)Kamiya Biomedical Company, LLC2025-04-18
Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge (K201256)Procise Diagnostics2022-11-04
Yumizen C1200 CRP (K192028)HORIBA ABX SAS2020-06-25
CRP Vario (K192118)SENTINEL CH. SpA2019-11-08
Yumizen C1200 CRP (K191993)HORIBA ABX SAS2019-10-03
VITROS Chemistry Products hsCRP Reagent (K160712)Ortho Clinical Diagnostics2017-07-14
QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument (K142993)Orion Diagnostica, OY2016-03-10
VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (K152433)Ortho Clinical Diagnostics2015-09-24
FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit (K141689)Qualigen, Inc.2015-01-07
DIAZYME HSCRP POC TEST KIT (K121558)Diazyme Laboratories2012-09-21
DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET (K103557)Diazyme Laboratories2011-04-27
ABX PENTRA 400 : CRP (K061138)Horiba Abx2006-09-29

Recalls involving this device

RecordFirmDate
The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model recall (Z-1178-2013)Alere San Diego, Inc.2013-04-25
Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech recall (Z-2457-2008)Cholestech Corp2008-09-20