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FDA 510(k)

UNIPAK TOTAL & DIRECT BILIRUBIN

K-Number: K771092 · 1977-07-21

ApplicantHarleco
Decision Date1977-07-21
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNIPAK TOTAL & DIRECT BILIRUBIN is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1977-07-21 under 510(k) number K771092. 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 UNIPAK TOTAL & DIRECT BILIRUBIN?

UNIPAK TOTAL & DIRECT BILIRUBIN is a medical device that received FDA 510(k) clearance on 1977-07-21. The listed applicant is Harleco. The 510(k) number is K771092.

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

UNIPAK TOTAL & DIRECT BILIRUBIN received FDA 510(k) clearance on 1977-07-21, under 510(k) number K771092.

Who is the listed applicant for UNIPAK TOTAL & DIRECT BILIRUBIN?

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

What is the FDA product code for UNIPAK TOTAL & DIRECT BILIRUBIN?

The FDA product code for UNIPAK TOTAL & 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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