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FDA 510(k)

IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP

K-Number: K063057 · 2006-12-22

ApplicantDiagnostic Products Corporation
Decision Date2006-12-22
Product CodeNQD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corporation. It received FDA 510(k) clearance on 2006-12-22 under 510(k) number K063057. 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/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP?

IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP is a medical device that received FDA 510(k) clearance on 2006-12-22. The listed applicant is Diagnostic Products Corporation. The 510(k) number is K063057.

When did IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP receive FDA 510(k) clearance?

IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP received FDA 510(k) clearance on 2006-12-22, under 510(k) number K063057.

Who is the listed applicant for IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP?

The FDA 510(k) record lists Diagnostic Products Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP?

The FDA product code for IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP is NQD.

Related Clinical Trials

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Other records listing Diagnostic Products Corporation 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.

K060929IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6K053533IMMULITE/IMMULITE 1000 TURBO INTACT PTH

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

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

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