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FDA 510(k)

VANTERA CLINICAL ANALYZER

K-Number: K113830 · 2012-08-30

ApplicantLiposcience
Decision Date2012-08-30
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VANTERA CLINICAL ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Liposcience. It received FDA 510(k) clearance on 2012-08-30 under 510(k) number K113830. The device is classified under product code CDT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VANTERA CLINICAL ANALYZER?

VANTERA CLINICAL ANALYZER is a medical device that received FDA 510(k) clearance on 2012-08-30. The listed applicant is Liposcience. The 510(k) number is K113830.

When did VANTERA CLINICAL ANALYZER receive FDA 510(k) clearance?

VANTERA CLINICAL ANALYZER received FDA 510(k) clearance on 2012-08-30, under 510(k) number K113830.

Who is the listed applicant for VANTERA CLINICAL ANALYZER?

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

What is the FDA product code for VANTERA CLINICAL ANALYZER?

The FDA product code for VANTERA CLINICAL ANALYZER is CDT.

Related Clinical Trials

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Other records listing Liposcience 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.

K063841NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS

Related Devices (Code: CDT)

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.

K133067ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENTSiemens Healthcare Diagnostics, Inc.K130332VITROS CHEMISTRY PRODUCTS TRIG SLIDESOrtho-Clinical Diagnostics, Inc.K102993ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SLSeppim S.A.S.K063804OLYMPUS TRIGLYCERIDE TEST SYSTEMOlympus America, Inc.K043546DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULEDade Behring, Inc.K034000VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATORClinical Data, 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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