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FDA 510(k)

DIRECT BILIRUBIN FOR DEMAND ANALYZER

K-Number: K850379 · 1985-03-01

ApplicantAdvanced Biomedical Methods, Inc.
Decision Date1985-03-01
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT BILIRUBIN FOR DEMAND ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biomedical Methods, Inc.. It received FDA 510(k) clearance on 1985-03-01 under 510(k) number K850379. 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 FOR DEMAND ANALYZER?

DIRECT BILIRUBIN FOR DEMAND ANALYZER is a medical device that received FDA 510(k) clearance on 1985-03-01. The listed applicant is Advanced Biomedical Methods, Inc.. The 510(k) number is K850379.

When did DIRECT BILIRUBIN FOR DEMAND ANALYZER receive FDA 510(k) clearance?

DIRECT BILIRUBIN FOR DEMAND ANALYZER received FDA 510(k) clearance on 1985-03-01, under 510(k) number K850379.

Who is the listed applicant for DIRECT BILIRUBIN FOR DEMAND ANALYZER?

The FDA 510(k) record lists Advanced Biomedical Methods, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIRECT BILIRUBIN FOR DEMAND ANALYZER?

The FDA product code for DIRECT BILIRUBIN FOR DEMAND ANALYZER is CIG.

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Other records listing Advanced Biomedical Methods, Inc. as applicant

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K945353CLARIT(TM)K880949SINGLE REAGENT CALCIUM FOR DEMAND ANALYZERK864866RESUBMISSION OF THE KLEERZIT REAGENTK852784ALKALINE PHOSPHATASEK852783SGOT/ALT REAGENTK852027GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER

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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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