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FDA 510(k)

WIENER LAB. BILIRUBINA DIRECT AA

K-Number: K024116 · 2003-02-12

ApplicantWiener Laboratories Saic
Decision Date2003-02-12
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WIENER LAB. BILIRUBINA DIRECT AA is the device name listed in this FDA 510(k) record. The listed applicant is Wiener Laboratories Saic. It received FDA 510(k) clearance on 2003-02-12 under 510(k) number K024116. 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 WIENER LAB. BILIRUBINA DIRECT AA?

WIENER LAB. BILIRUBINA DIRECT AA is a medical device that received FDA 510(k) clearance on 2003-02-12. The listed applicant is Wiener Laboratories Saic. The 510(k) number is K024116.

When did WIENER LAB. BILIRUBINA DIRECT AA receive FDA 510(k) clearance?

WIENER LAB. BILIRUBINA DIRECT AA received FDA 510(k) clearance on 2003-02-12, under 510(k) number K024116.

Who is the listed applicant for WIENER LAB. BILIRUBINA DIRECT AA?

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

What is the FDA product code for WIENER LAB. BILIRUBINA DIRECT AA?

The FDA product code for WIENER LAB. BILIRUBINA DIRECT AA is CIG.

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Other records listing Wiener Laboratories Saic as applicant

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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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