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FDA 510(k)

VIDAS CA 15-3 ASSAY

K-Number: K080469 · 2009-06-22

ApplicantbioMerieux, Inc.
Decision Date2009-06-22
Product CodeLTK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VIDAS CA 15-3 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2009-06-22 under 510(k) number K080469. 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 VIDAS CA 15-3 ASSAY?

VIDAS CA 15-3 ASSAY is a medical device that received FDA 510(k) clearance on 2009-06-22. The listed applicant is bioMerieux, Inc.. The 510(k) number is K080469.

When did VIDAS CA 15-3 ASSAY receive FDA 510(k) clearance?

VIDAS CA 15-3 ASSAY received FDA 510(k) clearance on 2009-06-22, under 510(k) number K080469.

Who is the listed applicant for VIDAS CA 15-3 ASSAY?

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

What is the FDA product code for VIDAS CA 15-3 ASSAY?

The FDA product code for VIDAS CA 15-3 ASSAY is LTK.

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Related Devices (Code: LTK)

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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 DiagnosticsK080561VIDAS CA 125 II 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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