Elecsys PTH , Elecsys PTH STAT
K-Number: K231927 · 2024-03-22
ApplicantRoche Diagnostics
Decision Date2024-03-22
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Elecsys PTH , Elecsys PTH STAT is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2024-03-22 under approval number K231927. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Elecsys PTH , Elecsys PTH STAT?
Elecsys PTH , Elecsys PTH STAT is a medical device that received FDA 510(k) clearance on 2024-03-22. It is manufactured by Roche Diagnostics. The 510(k) number is K231927.
When was Elecsys PTH , Elecsys PTH STAT approved by the FDA?
Elecsys PTH , Elecsys PTH STAT received FDA 510(k) clearance on 2024-03-22, under approval number K231927.
What company makes Elecsys PTH , Elecsys PTH STAT?
Elecsys PTH , Elecsys PTH STAT is manufactured by Roche Diagnostics.
What is the FDA product code for Elecsys PTH , Elecsys PTH STAT?
The FDA product code for Elecsys PTH , Elecsys PTH STAT is CEW.
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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.