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 a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2025-02-07 under approval 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. It is manufactured by Roche Diagnostics. The 510(k) number is K241453.
When was Elecsys sFlt-1 and Elecsys PlGF approved by the FDA?
Elecsys sFlt-1 and Elecsys PlGF received FDA 510(k) clearance on 2025-02-07, under approval number K241453.
What company makes Elecsys sFlt-1 and Elecsys PlGF?
Elecsys sFlt-1 and Elecsys PlGF is manufactured by Roche Diagnostics.
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.
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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.