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FDA 510(k)

IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)

K-Number: K071017 · 2007-05-02

ApplicantSiemens Medical Solutions Diagnostics
Decision Date2007-05-02
Product CodeNQD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions Diagnostics. It received FDA 510(k) clearance on 2007-05-02 under 510(k) number K071017. The device is classified under product code NQD. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)?

IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) is a medical device that received FDA 510(k) clearance on 2007-05-02. The listed applicant is Siemens Medical Solutions Diagnostics. The 510(k) number is K071017.

When did IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) receive FDA 510(k) clearance?

IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) received FDA 510(k) clearance on 2007-05-02, under 510(k) number K071017.

Who is the listed applicant for IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)?

The FDA 510(k) record lists Siemens Medical Solutions Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)?

The FDA product code for IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) is NQD.

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Other records listing Siemens Medical Solutions Diagnostics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K100910IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6K091984IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6K081895ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORSK071455ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATORK073537NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265K072658ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS

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Related Devices (Code: NQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260026Tina-quant Cardiac high sensitivity CRP IIIRoche DiagnosticsK233242Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics, Inc.K212559CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbHK173833CRP VarioSENTINEL CH. SpAK081294ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORSSiemens Healthcare Diagnostics, Inc.K071002IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENTBeckman Coulter, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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