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FDA 510(k)

Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF

K-Number: K231348 · 2023-06-05

ApplicantRoche Diagnostics
Decision Date2023-06-05
Product CodeQSE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2023-06-05 under 510(k) number K231348. The device is classified under product code QSE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF?

Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF is a medical device that received FDA 510(k) clearance on 2023-06-05. The listed applicant is Roche Diagnostics. The 510(k) number is K231348.

When did Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF receive FDA 510(k) clearance?

Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF received FDA 510(k) clearance on 2023-06-05, under 510(k) number K231348.

Who is the listed applicant for Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF?

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 ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF?

The FDA product code for Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF is QSE.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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