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FDA 510(k)

ARCHITECT CA 15-3 ASSAY

K-Number: K042732 · 2004-12-22

ApplicantFujirebio Diagnostics,Inc.
Decision Date2004-12-22
Product CodeMOI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ARCHITECT CA 15-3 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 2004-12-22 under 510(k) number K042732. 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 ARCHITECT CA 15-3 ASSAY?

ARCHITECT CA 15-3 ASSAY is a medical device that received FDA 510(k) clearance on 2004-12-22. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K042732.

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

ARCHITECT CA 15-3 ASSAY received FDA 510(k) clearance on 2004-12-22, under 510(k) number K042732.

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

The FDA product code for ARCHITECT CA 15-3 ASSAY is MOI.

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Related Devices (Code: MOI)

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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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