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FDA 510(k)

DIRECT BILIRUBIN REAGENT

K-Number: K840777 · 1984-04-05

ApplicantAmerican Dade
Decision Date1984-04-05
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT BILIRUBIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1984-04-05 under 510(k) number K840777. 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 DIRECT BILIRUBIN REAGENT?

DIRECT BILIRUBIN REAGENT is a medical device that received FDA 510(k) clearance on 1984-04-05. The listed applicant is American Dade. The 510(k) number is K840777.

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

DIRECT BILIRUBIN REAGENT received FDA 510(k) clearance on 1984-04-05, under 510(k) number K840777.

Who is the listed applicant for DIRECT BILIRUBIN REAGENT?

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

What is the FDA product code for DIRECT BILIRUBIN REAGENT?

The FDA product code for DIRECT BILIRUBIN REAGENT 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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