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FDA 510(k)

ARCHITECT CA 125 II ASSAY

K-Number: K042731 · 2004-11-19

ApplicantFujirebio Diagnostics,Inc.
Decision Date2004-11-19
Product CodeLTK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ARCHITECT CA 125 II ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2004-11-19 under 510(k) number K042731. 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 ARCHITECT CA 125 II ASSAY?

ARCHITECT CA 125 II ASSAY is a medical device that received FDA 510(k) clearance on 2004-11-19. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K042731.

When did ARCHITECT CA 125 II ASSAY receive FDA 510(k) clearance?

ARCHITECT CA 125 II ASSAY received FDA 510(k) clearance on 2004-11-19, under 510(k) number K042731.

Who is the listed applicant for ARCHITECT CA 125 II ASSAY?

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

What is the FDA product code for ARCHITECT CA 125 II ASSAY?

The FDA product code for ARCHITECT CA 125 II ASSAY is LTK.

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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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