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FDA 510(k)

VITALAB DIRECT BILIRUBIN REAGENT

K-Number: K040631 · 2004-03-18

ApplicantClinical Data, Inc.
Decision Date2004-03-18
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITALAB DIRECT BILIRUBIN REAGENT 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 2004-03-18 under 510(k) number K040631. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALAB DIRECT BILIRUBIN REAGENT?

VITALAB DIRECT BILIRUBIN REAGENT is a medical device that received FDA 510(k) clearance on 2004-03-18. The listed applicant is Clinical Data, Inc.. The 510(k) number is K040631.

When did VITALAB DIRECT BILIRUBIN REAGENT receive FDA 510(k) clearance?

VITALAB DIRECT BILIRUBIN REAGENT received FDA 510(k) clearance on 2004-03-18, under 510(k) number K040631.

Who is the listed applicant for VITALAB DIRECT BILIRUBIN REAGENT?

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 DIRECT BILIRUBIN REAGENT?

The FDA product code for VITALAB DIRECT BILIRUBIN REAGENT is CIG.

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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 REAGENTK040534VITALAB AMYLASE REAGENTK034000VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATORK040508VITALAB MAGNESIUM REAGENT

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Related Devices (Code: CIG)

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.

K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc.K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223324Total Bilirubin2Abbott Ireland Diagnostics DivisionK190807VITROS XT Chemistry Products TBIL-ALKP SlidesOrtho-Clinical Diagnostics, Inc.K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1Elitechgroup

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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