Atlas FDA

CardioPhase® hsCRP

FDA 510(k) clearance K212559 · decided 2022-12-16

Clearance details

K-number
K212559
Device name
CardioPhase® hsCRP
Applicant
Siemens Healthcare Diagnostics Products GmbH
Decision
Substantially Equivalent
Date received
2021-08-13
Decision date
2022-12-16
Days to decision
490 days
Clearance type
Special
Product code
NQD
Device class
2
Regulation number
866.5270
Medical specialty
Immunology
Advisory committee
Immunology
Location
Marburg, DE
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Tina-quant Cardiac high sensitivity CRP III (K260026)Roche Diagnostics2026-04-02
Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) (K233242)Siemens Healthcare Diagnostics, Inc.2024-01-18
CRP Vario (K173833)SENTINEL CH. SpA2018-09-27
ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS (K081294)Siemens Healthcare Diagnostics, Inc.2008-07-29
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT (K071002)Beckman Coulter, Inc.2007-06-21
SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT (K070626)Beckman Coulter, Inc.2007-05-04
IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) (K071017)Siemens Medical Solutions Diagnostics2007-05-02
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK (K062924)Dade Behring, Inc.2006-12-26
IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP (K063057)Diagnostic Products Corporation2006-12-22
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH (K061802)Dade Behring, Inc.2006-09-11
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK (K060369)Dade Behring, Inc.2006-05-04
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS (K053603)Roche Diagnostics Corp.2006-02-09

Recalls involving this device

No recalls on record reference this clearance.