Home / 510(k) Clearances / K232624

510(k) K232624

CardioPhase® hsCRP by Siemens Healthcare Diagnostic Products GmbH — Product Code DCN

K232624 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostic Products GmbH for the device "CardioPhase® hsCRP". The FDA issued a decision of Substantially Equivalent on November 27, 2023. The device falls under product code DCN (System, Test, C-Reactive Protein), a Class II device regulated under 21 CFR 866.5270. Siemens Healthcare Diagnostic Products GmbH has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2023
Date Received
August 29, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, C-Reactive Protein
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

Other clearances by Siemens Healthcare Diagnostic Products GmbH

  • K242952 — INNOVANCE Antithrombin (March 28, 2025)
  • K172286 — Automated Blood Coagulation Analyzer CS-2500 (December 18, 2017)
  • K150678 — Sysmex Automated Blood Coagulation Analyzer CS-5100 (January 11, 2016)

Other clearances for product code DCN

  • K221119 — RCRP Flex reagent cartridge (March 17, 2023)
  • K192072 — Tina-quant C-Reactive Protein IV (February 21, 2020)
  • K180099 — Optilite High Sensitivity C-Reactive Protein Kit (October 12, 2018)
  • K172868 — Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optil (February 28, 2018)
  • K171498 — MSD CRP Assay Kit and MESO SECTOR S 700 Instrument (January 12, 2018)
  • K161982 — C-Reactive Protein Kit for use on SPAPLUS (April 5, 2017)
  • K113809 — HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) (August 17, 2012)
  • K091052 — PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM (January 15, 2010)
  • K083444 — C-REACTIVE PROTEIN (LATEX) (March 18, 2009)
  • K083412 — PATHFAST HSCRP (March 9, 2009)

FDA data resources