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FDA 510(k)

CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM

K-Number: K020828 · 2002-07-24

ApplicantBayer Corp.
Decision Date2002-07-24
Product CodeLTK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 2002-07-24 under 510(k) number K020828. The device is classified under product code LTK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM?

CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM is a medical device that received FDA 510(k) clearance on 2002-07-24. The listed applicant is Bayer Corp.. The 510(k) number is K020828.

When did CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM receive FDA 510(k) clearance?

CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM received FDA 510(k) clearance on 2002-07-24, under 510(k) number K020828.

Who is the listed applicant for CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM?

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

What is the FDA product code for CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM?

The FDA product code for CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM is LTK.

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Other records listing Bayer 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.

K024062ASCENSIA BREEZE BLOOD GLUCOSE METERK023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTK024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE SYSTEM

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Related Devices (Code: LTK)

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.

K240479Access OV MonitorBeckman Coulter, Inc.K213510IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MASiemens Healthcare Diagnostics Products, Ltd.K221355VITROS Immuodiagnostic Products CA 125 II Reagent PackOrtho Clinical DiagnosticsK200199ADVIA Centaur CA 125IISiemens Healthcare Diagnostics, Inc.K100321DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604Siemens Healthcare DiagnosticsK080469VIDAS CA 15-3 ASSAYbioMerieux, 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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