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FDA 510(k)

VIDAS CEA (S) ASSAY

K-Number: K080194 · 2008-10-09

ApplicantbioMerieux, Inc.
Decision Date2008-10-09
Product CodeDHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VIDAS CEA (S) 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 2008-10-09 under 510(k) number K080194. The device is classified under product code DHX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDAS CEA (S) ASSAY?

VIDAS CEA (S) ASSAY is a medical device that received FDA 510(k) clearance on 2008-10-09. The listed applicant is bioMerieux, Inc.. The 510(k) number is K080194.

When did VIDAS CEA (S) ASSAY receive FDA 510(k) clearance?

VIDAS CEA (S) ASSAY received FDA 510(k) clearance on 2008-10-09, under 510(k) number K080194.

Who is the listed applicant for VIDAS CEA (S) 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 CEA (S) ASSAY?

The FDA product code for VIDAS CEA (S) ASSAY is DHX.

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K223921Access CEABeckman Coulter, Inc.K231517VITROS Immunodiagnostic Products CEA Reagent PackOrtho Clinical DiagnosticsK200215ADVIA Centaur CEA AssaySiemens Healthcare Disgnostics, Inc.K081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENOlympus America, Inc.K071603DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)Dade Behring, Inc.K041322VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERSOrtho-Clinical Diagnostics, 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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