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510(k) K060369

STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK by Dade Behring, Inc. — Product Code NQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2006
Date Received
February 13, 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.

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  • K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (February 21, 2008)
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  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

Other clearances for product code NQD

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  • 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)
  • K061802 — DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, (September 11, 2006)