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FDA 510(k)

COBAS INTEGRA BILIRUBIN DIRECT GEN.2

K-Number: K123965 · 2013-02-28

ApplicantRoche Diagnostics
Decision Date2013-02-28
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS INTEGRA BILIRUBIN DIRECT GEN.2 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2013-02-28 under 510(k) number K123965. 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 COBAS INTEGRA BILIRUBIN DIRECT GEN.2?

COBAS INTEGRA BILIRUBIN DIRECT GEN.2 is a medical device that received FDA 510(k) clearance on 2013-02-28. The listed applicant is Roche Diagnostics. The 510(k) number is K123965.

When did COBAS INTEGRA BILIRUBIN DIRECT GEN.2 receive FDA 510(k) clearance?

COBAS INTEGRA BILIRUBIN DIRECT GEN.2 received FDA 510(k) clearance on 2013-02-28, under 510(k) number K123965.

Who is the listed applicant for COBAS INTEGRA BILIRUBIN DIRECT GEN.2?

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

What is the FDA product code for COBAS INTEGRA BILIRUBIN DIRECT GEN.2?

The FDA product code for COBAS INTEGRA BILIRUBIN DIRECT GEN.2 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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