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FDA 510(k)

BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY

K-Number: K012183 · 2001-12-27

ApplicantBayer Diagnostics Corp.
Decision Date2001-12-27
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Diagnostics Corp.. It received FDA 510(k) clearance on 2001-12-27 under 510(k) number K012183. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY?

BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY is a medical device that received FDA 510(k) clearance on 2001-12-27. The listed applicant is Bayer Diagnostics Corp.. The 510(k) number is K012183.

When did BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY receive FDA 510(k) clearance?

BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY received FDA 510(k) clearance on 2001-12-27, under 510(k) number K012183.

Who is the listed applicant for BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY?

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

What is the FDA product code for BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY?

The FDA product code for BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY is LGD.

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Other records listing Bayer Diagnostics Corp. as applicant

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.

K033379BAYER SPECIAL CHEMISTRY CONTROLSK033380BAYER SPECIAL CHEMISTRY CALIBRATORSK033007BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEMK031857ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAYK022096URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMK030452BAYER LIGAND PLUS 1, 2, 3 CONTROLS

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Related Devices (Code: LGD)

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.

K242022Access Toxo IgGBeckman Coulter, Inc.K242095Access Toxo IgM IIBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott LaboratoriesK210596ARCHITECT Toxo IgGAbbott LaboratoriesK162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche DiagnosticsK132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IIDiaSorin, Inc.

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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