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FDA 510(k)

WIENER LAB. BILIRRUBINA TOTAL AA

K-Number: K022962 · 2002-11-01

ApplicantWiener Laboratories Saic
Decision Date2002-11-01
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WIENER LAB. BILIRRUBINA TOTAL 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 2002-11-01 under 510(k) number K022962. 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. BILIRRUBINA TOTAL AA?

WIENER LAB. BILIRRUBINA TOTAL AA is a medical device that received FDA 510(k) clearance on 2002-11-01. The listed applicant is Wiener Laboratories Saic. The 510(k) number is K022962.

When did WIENER LAB. BILIRRUBINA TOTAL AA receive FDA 510(k) clearance?

WIENER LAB. BILIRRUBINA TOTAL AA received FDA 510(k) clearance on 2002-11-01, under 510(k) number K022962.

Who is the listed applicant for WIENER LAB. BILIRRUBINA TOTAL 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. BILIRRUBINA TOTAL AA?

The FDA product code for WIENER LAB. BILIRRUBINA TOTAL AA is CIG.

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Other records listing Wiener Laboratories Saic as applicant

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K023889WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254K024305WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006K024116WIENER LAB. BILIRUBINA DIRECT AAK023992WIENER LAB COLINESTERASA AAK023744WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354K023551WIENER LAB GOT (AST) UV AA LIQUIDA

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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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