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FDA 510(k)

BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR.

K-Number: K770458 · 1977-05-10

ApplicantIcn Pharmaceuticals, Inc.
Decision Date1977-05-10
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. is the device name listed in this FDA 510(k) record. The listed applicant is Icn Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1977-05-10 under 510(k) number K770458. 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 PROCEDURE, TEKPOINT TOT & DIR.?

BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. is a medical device that received FDA 510(k) clearance on 1977-05-10. The listed applicant is Icn Pharmaceuticals, Inc.. The 510(k) number is K770458.

When did BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. receive FDA 510(k) clearance?

BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. received FDA 510(k) clearance on 1977-05-10, under 510(k) number K770458.

Who is the listed applicant for BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR.?

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

What is the FDA product code for BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR.?

The FDA product code for BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. 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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