Atlas FDA

CardioPhase® hsCRP

FDA 510(k) clearance K232624 · decided 2023-11-27

Clearance details

K-number
K232624
Device name
CardioPhase® hsCRP
Applicant
Siemens Healthcare Diagnostic Products GmbH
Decision
Substantially Equivalent
Date received
2023-08-29
Decision date
2023-11-27
Days to decision
90 days
Clearance type
Traditional
Product code
DCN
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
RCRP Flex reagent cartridge (K221119)Siemens Healthcare Diagnostics, Inc.2023-03-17
Tina-quant C-Reactive Protein IV (K192072)Roche Diagnostics Operations (Rdo)2020-02-21
Optilite High Sensitivity C-Reactive Protein Kit (K180099)The Binding Site Group , Ltd.2018-10-12
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls (K172868)The Binding Site Group , Ltd.2018-02-28
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument (K171498)Meso Scale Diagnostics, LLC2018-01-12
C-Reactive Protein Kit for use on SPAPLUS (K161982)The Binding Site Group2017-04-05
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) (K113809)Hitachi Chemical Diagnostics, Inc.2012-08-17
PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM (K091052)Abaxis, Inc.2010-01-15
C-REACTIVE PROTEIN (LATEX) (K083444)Roche Diagnostics Corp.2009-03-18
PATHFAST HSCRP (K083412)Mitsubishi Kagaku Iatron2009-03-09
S-TEST C-REACTIVE PROTEIN (CRP) (K083040)Alfa Wassermann Diagnostic Technologies, Inc.2009-01-30
ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS (K072658)Siemens Medical Solutions Diagnostics2008-04-01

Recalls involving this device

No recalls on record reference this clearance.