CRP-LATEX (II)X2 SEIKEN ASSAY KIT— 510(k) K030545

Clearance details

Applicant

Denka Seiken Co., Ltd.

Product code

Code DCK

Device class

Class 2

Regulation

21 CFR 866.5270

Advisory panel

Immunology

Date received

2003-02-20

Decision date

2003-06-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Gosen City, Niigata, JP

• 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

• K161679 — s LDL-EX SEIKEN2017-08-18
• K060359 — ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-102006-04-14
• K043264 — LDL-EX SEIKEN ASSAY KIT2005-01-26
• K041090 — HDL-EX SEIKEN ASSAY KIT2004-10-29
• K030546 — CRP (II) CALIBRATORS2003-06-02

• Z-2631-2017 — Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use onlyClass III·Terminated·Medtest Holdings, Inc.·20090721

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030545.