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FDA 510(k)

Elecsys CA 15-3 II

K-Number: K181492 · 2018-06-22

ApplicantRoche Diagnostics
Decision Date2018-06-22
Product CodeMOI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Elecsys CA 15-3 II is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2018-06-22 under 510(k) number K181492. 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 2018-06-22. The listed applicant is Roche Diagnostics. The 510(k) number is K181492.

When did Elecsys CA 15-3 II receive FDA 510(k) clearance?

Elecsys CA 15-3 II received FDA 510(k) clearance on 2018-06-22, under 510(k) number K181492.

Who is the listed applicant for Elecsys CA 15-3 II?

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

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)

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.

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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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