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FDA 510(k)

ULTRACHEM T-BILI 64971 GILFORD 3500

K-Number: K780524 · 1978-05-19

ApplicantHarleco
Decision Date1978-05-19
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRACHEM T-BILI 64971 GILFORD 3500 is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1978-05-19 under 510(k) number K780524. 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 ULTRACHEM T-BILI 64971 GILFORD 3500?

ULTRACHEM T-BILI 64971 GILFORD 3500 is a medical device that received FDA 510(k) clearance on 1978-05-19. The listed applicant is Harleco. The 510(k) number is K780524.

When did ULTRACHEM T-BILI 64971 GILFORD 3500 receive FDA 510(k) clearance?

ULTRACHEM T-BILI 64971 GILFORD 3500 received FDA 510(k) clearance on 1978-05-19, under 510(k) number K780524.

Who is the listed applicant for ULTRACHEM T-BILI 64971 GILFORD 3500?

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 ULTRACHEM T-BILI 64971 GILFORD 3500?

The FDA product code for ULTRACHEM T-BILI 64971 GILFORD 3500 is CIG.

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Other records listing Harleco as applicant

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K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DHK813044ULTRACHEM ALB, ITEM #64970K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813038ULTRACHEM TP, ITEM #64974K813041ULTRAZYME-GT, ITEM #64959 & 65032

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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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