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FDA 510(k)

CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM

K-Number: K012357 · 2002-02-28

ApplicantBayer Diagnostics Corp.
Decision Date2002-02-28
Product CodeMOI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM 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 2002-02-28 under 510(k) number K012357. The device is classified under product code MOI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM?

CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM is a medical device that received FDA 510(k) clearance on 2002-02-28. The listed applicant is Bayer Diagnostics Corp.. The 510(k) number is K012357.

When did CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM receive FDA 510(k) clearance?

CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM received FDA 510(k) clearance on 2002-02-28, under 510(k) number K012357.

Who is the listed applicant for CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM?

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 CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM?

The FDA product code for CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM is MOI.

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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: MOI)

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.

K240403Access BR MonitorBeckman Coulter, Inc.K233946IMMULITE® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd.K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc.K193489ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc.K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc.K181492Elecsys CA 15-3 IIRoche Diagnostics

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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