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FDA 510(k)

ROCHE REAGENT FOR DIRECT BILIRUBIN

K-Number: K910593 · 1991-04-24

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1991-04-24
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE REAGENT FOR DIRECT BILIRUBIN is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1991-04-24 under 510(k) number K910593. 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 ROCHE REAGENT FOR DIRECT BILIRUBIN?

ROCHE REAGENT FOR DIRECT BILIRUBIN is a medical device that received FDA 510(k) clearance on 1991-04-24. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K910593.

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

ROCHE REAGENT FOR DIRECT BILIRUBIN received FDA 510(k) clearance on 1991-04-24, under 510(k) number K910593.

Who is the listed applicant for ROCHE REAGENT FOR DIRECT BILIRUBIN?

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

What is the FDA product code for ROCHE REAGENT FOR DIRECT BILIRUBIN?

The FDA product code for ROCHE REAGENT FOR DIRECT 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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