Elecsys AMH
K-Number: K203757 · 2022-06-10
ApplicantRoche Diagnostics
Decision Date2022-06-10
Product CodePQO
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Elecsys AMH is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2022-06-10 under approval number K203757. The device is classified under product code PQO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Elecsys AMH?
Elecsys AMH is a medical device that received FDA 510(k) clearance on 2022-06-10. It is manufactured by Roche Diagnostics. The 510(k) number is K203757.
When was Elecsys AMH approved by the FDA?
Elecsys AMH received FDA 510(k) clearance on 2022-06-10, under approval number K203757.
What company makes Elecsys AMH?
Elecsys AMH is manufactured by Roche Diagnostics.
What is the FDA product code for Elecsys AMH?
The FDA product code for Elecsys AMH is PQO.
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Related Devices (Code: PQO)
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.