Atlas FDA

N HIGH SENSITIVITY CRP

FDA 510(k) clearance K033908 · decided 2004-01-22

Clearance details

K-number
K033908
Device name
N HIGH SENSITIVITY CRP
Applicant
Dade Behring, Inc.
Decision
Substantially Equivalent
Date received
2003-12-17
Decision date
2004-01-22
Days to decision
36 days
Clearance type
Traditional
Product code
NQD
Device class
2
Regulation number
866.5270
Medical specialty
Immunology
Advisory committee
Immunology
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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

RecordFirmDate
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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
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003)Dade Behring, Inc.2002-07-24
COBAS INTEGRA CYCLOSPORINE (P920031/S002)Dade Behring, Inc.2002-02-26
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001)Dade Behring, Inc.2000-08-11
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031)Dade Behring, Inc.1996-10-02