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510(k) K233242

Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) by Siemens Healthcare Diagnostics, Inc. — Product Code NQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2024
Date Received
September 28, 2023
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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Other clearances for product code NQD

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  • 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)
  • K060369 — STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK (May 4, 2006)