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FDA 510(k)

IQ/QCA TOTAL BILIRUBIN

K-Number: K874261 · 1987-11-25

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1987-11-25
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IQ/QCA TOTAL BILIRUBIN is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1987-11-25 under 510(k) number K874261. 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 IQ/QCA TOTAL BILIRUBIN?

IQ/QCA TOTAL BILIRUBIN is a medical device that received FDA 510(k) clearance on 1987-11-25. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K874261.

When did IQ/QCA TOTAL BILIRUBIN receive FDA 510(k) clearance?

IQ/QCA TOTAL BILIRUBIN received FDA 510(k) clearance on 1987-11-25, under 510(k) number K874261.

Who is the listed applicant for IQ/QCA TOTAL BILIRUBIN?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IQ/QCA TOTAL BILIRUBIN?

The FDA product code for IQ/QCA TOTAL BILIRUBIN is CIG.

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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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