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FDA 510(k)

BILIRUBIN TOTAL DIRECT

K-Number: K863057 · 1986-09-26

ApplicantJ. D. Assoc.
Decision Date1986-09-26
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILIRUBIN TOTAL DIRECT is the device name listed in this FDA 510(k) record. The listed applicant is J. D. Assoc.. It received FDA 510(k) clearance on 1986-09-26 under 510(k) number K863057. 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 BILIRUBIN TOTAL DIRECT?

BILIRUBIN TOTAL DIRECT is a medical device that received FDA 510(k) clearance on 1986-09-26. The listed applicant is J. D. Assoc.. The 510(k) number is K863057.

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

BILIRUBIN TOTAL DIRECT received FDA 510(k) clearance on 1986-09-26, under 510(k) number K863057.

Who is the listed applicant for BILIRUBIN TOTAL DIRECT?

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

What is the FDA product code for BILIRUBIN TOTAL DIRECT?

The FDA product code for BILIRUBIN TOTAL DIRECT is CIG.

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Other records listing J. D. Assoc. as applicant

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.

K863054AST S.C.E. (GOT)K863103PEG 6,000K863069MAGNESIOMETERK863079CREATINKINETICK863112PROTEINMETERK863053ALT S.C.E. (GPT)

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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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