Home / 510(k) Clearances / K152433

510(k) K152433

VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 by Ortho Clinical Diagnostics — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2015
Date Received
August 27, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

Other clearances by Ortho Clinical Diagnostics

  • K241534 — VITROS Immunodiagnostic Products Syphilis Reagent Pack (August 28, 2024)
  • K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (May 8, 2024)
  • K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent Pack (September 5, 2023)
  • K231517 — VITROS Immunodiagnostic Products CEA Reagent Pack (August 23, 2023)
  • K231525 — VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack (August 9, 2023)
  • K221355 — VITROS Immuodiagnostic Products CA 125 II Reagent Pack (December 12, 2022)
  • K213626 — VITROS AFP (June 15, 2022)
  • K212648 — VITROS Immunodiagnostic Products CK-MB Reagent Pack (January 28, 2022)
  • K201312 — VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack (October 4, 2021)
  • K200236 — VITROS BRAHMS PCT Reagent Pack and Calibrators (February 25, 2020)

Other clearances for product code DCK

  • K242170 — K-ASSAY CRP (Ver.2) (April 18, 2025)
  • K201256 — Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge (November 4, 2022)
  • K192028 — Yumizen C1200 CRP (June 25, 2020)
  • K192118 — CRP Vario (November 8, 2019)
  • K191993 — Yumizen C1200 CRP (October 3, 2019)
  • K160712 — VITROS Chemistry Products hsCRP Reagent (July 14, 2017)
  • K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, (March 10, 2016)
  • K141689 — FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Rea (January 7, 2015)
  • K121558 — DIAZYME HSCRP POC TEST KIT (September 21, 2012)
  • K103557 — DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET (April 27, 2011)