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FDA 510(k)

Elecsys sFlt-1 and Elecsys PlGF

K-Number: K241453 · 2025-02-07

ApplicantRoche Diagnostics
Decision Date2025-02-07
Product CodeQWH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Elecsys sFlt-1 and Elecsys PlGF is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2025-02-07 under 510(k) number K241453. The device is classified under product code QWH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys sFlt-1 and Elecsys PlGF?

Elecsys sFlt-1 and Elecsys PlGF is a medical device that received FDA 510(k) clearance on 2025-02-07. The listed applicant is Roche Diagnostics. The 510(k) number is K241453.

When did Elecsys sFlt-1 and Elecsys PlGF receive FDA 510(k) clearance?

Elecsys sFlt-1 and Elecsys PlGF received FDA 510(k) clearance on 2025-02-07, under 510(k) number K241453.

Who is the listed applicant for Elecsys sFlt-1 and Elecsys PlGF?

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 sFlt-1 and Elecsys PlGF?

The FDA product code for Elecsys sFlt-1 and Elecsys PlGF is QWH.

Other records listing Roche Diagnostics as applicant

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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