Home / 510(k) Clearances / K192118

510(k) K192118

CRP Vario by SENTINEL CH. SpA — Product Code DCK

K192118 is an FDA 510(k) premarket notification submitted by SENTINEL CH. SpA for the device "CRP Vario". The FDA issued a decision of Substantially Equivalent on November 8, 2019. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. SENTINEL CH. SpA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2019
Date Received
August 6, 2019
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 SENTINEL CH. SpA

  • K242585 — Cystatin C (May 16, 2025)
  • K211058 — Lp(a) Ultra (December 22, 2022)
  • K193001 — Albumin BCP (December 19, 2019)
  • K173833 — CRP Vario (September 27, 2018)
  • K141728 — ACE CALIBRATOR (July 28, 2014)
  • K102706 — CKMB UDR ASSAY (August 19, 2011)
  • K083602 — KAPPA LIGHT CHAINS (September 3, 2009)
  • K083601 — LAMBDA LIGHT CHAINS (June 22, 2009)
  • K081533 — SENTINEL PLASMAPROTEINS CAL 3X (June 25, 2008)
  • K073634 — MULTIGENT CREATININE (ENZYMATIC) ASSAY (June 19, 2008)

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)
  • 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)
  • K152433 — VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (September 24, 2015)
  • 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)

FDA data resources