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FDA 510(k)

VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR

K-Number: K034000 · 2004-03-10

ApplicantClinical Data, Inc.
Decision Date2004-03-10
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Data, Inc.. It received FDA 510(k) clearance on 2004-03-10 under 510(k) number K034000. 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 VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR?

VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR is a medical device that received FDA 510(k) clearance on 2004-03-10. The listed applicant is Clinical Data, Inc.. The 510(k) number is K034000.

When did VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR receive FDA 510(k) clearance?

VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR received FDA 510(k) clearance on 2004-03-10, under 510(k) number K034000.

Who is the listed applicant for VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR?

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

What is the FDA product code for VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR?

The FDA product code for VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR is CDT.

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Other records listing Clinical Data, Inc. 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.

K071706ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)K052591NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KITK033983VITALAB IRON REAGENTK040631VITALAB DIRECT BILIRUBIN REAGENTK040534VITALAB AMYLASE REAGENTK040508VITALAB MAGNESIUM REAGENT

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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.K113830VANTERA CLINICAL ANALYZERLiposcienceK102993ELITECH 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.

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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