FDA 510(k)

Elecsys CA 15-3 II

K-Number: K171605 · 2018-02-20

Decision Date2018-02-20

Product CodeMOI

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

Elecsys CA 15-3 II is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2018-02-20 under approval number K171605. 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 Elecsys CA 15-3 II?

Elecsys CA 15-3 II is a medical device that received FDA 510(k) clearance on 2018-02-20. It is manufactured by Roche Diagnostics. The 510(k) number is K171605.

When was Elecsys CA 15-3 II approved by the FDA?

Elecsys CA 15-3 II received FDA 510(k) clearance on 2018-02-20, under approval number K171605.

What company makes Elecsys CA 15-3 II?

Elecsys CA 15-3 II is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys CA 15-3 II?

The FDA product code for Elecsys CA 15-3 II is MOI.

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Related Devices (Code: MOI)

K181492Elecsys CA 15-3 IIRoche Diagnostics K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc. K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc. K193489ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc. K240403Access BR MonitorBeckman Coulter, Inc. K233946IMMULITE® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd.

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.