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FDA 510(k)

COBAS INTEGRA 400/800 BILIRUBIN TOTAL

K-Number: K081193 · 2009-01-16

ApplicantRoche Diagnostics
Decision Date2009-01-16
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS INTEGRA 400/800 BILIRUBIN TOTAL is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2009-01-16 under 510(k) number K081193. 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 400/800 BILIRUBIN TOTAL?

COBAS INTEGRA 400/800 BILIRUBIN TOTAL is a medical device that received FDA 510(k) clearance on 2009-01-16. The listed applicant is Roche Diagnostics. The 510(k) number is K081193.

When did COBAS INTEGRA 400/800 BILIRUBIN TOTAL receive FDA 510(k) clearance?

COBAS INTEGRA 400/800 BILIRUBIN TOTAL received FDA 510(k) clearance on 2009-01-16, under 510(k) number K081193.

Who is the listed applicant for COBAS INTEGRA 400/800 BILIRUBIN TOTAL?

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 400/800 BILIRUBIN TOTAL?

The FDA product code for COBAS INTEGRA 400/800 BILIRUBIN TOTAL 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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