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510(k) K061802

DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH by Dade Behring, Inc. — Product Code NQD

K061802 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH". The FDA issued a decision of Substantially Equivalent on September 11, 2006. The device falls under product code NQD (Cardiac C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2006
Date Received
June 27, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.

Other clearances by Dade Behring, Inc.

  • K093848 — PT-MULTI-CALIBRATOR, MODEL OPAT07 (December 20, 2010)
  • K081161 — DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEI (July 28, 2008)
  • K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROT (July 21, 2008)
  • K071603 — DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) (June 25, 2008)
  • K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (June 4, 2008)
  • K073604 — DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CAR (March 13, 2008)
  • K073561 — DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA (February 26, 2008)
  • K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (February 21, 2008)
  • K073055 — DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 (January 3, 2008)
  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

Other clearances for product code NQD

  • K260026 — Tina-quant Cardiac high sensitivity CRP III (April 2, 2026)
  • K233242 — Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) (January 18, 2024)
  • K212559 — CardioPhase® hsCRP (December 16, 2022)
  • K173833 — CRP Vario (September 27, 2018)
  • K081294 — ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRA (July 29, 2008)
  • K071002 — IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP (June 21, 2007)
  • K070626 — SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT (May 4, 2007)
  • K071017 — IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5 (May 2, 2007)
  • K062924 — STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK (December 26, 2006)
  • K063057 — IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP (December 22, 2006)

FDA data resources