Elecsys Tg II
K-Number: K221890 · 2023-09-30
ApplicantRoche Diagnostics
Decision Date2023-09-30
Product CodeMSW
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Elecsys Tg II is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2023-09-30 under approval number K221890. The device is classified under product code MSW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Elecsys Tg II?
Elecsys Tg II is a medical device that received FDA 510(k) clearance on 2023-09-30. It is manufactured by Roche Diagnostics. The 510(k) number is K221890.
When was Elecsys Tg II approved by the FDA?
Elecsys Tg II received FDA 510(k) clearance on 2023-09-30, under approval number K221890.
What company makes Elecsys Tg II?
Elecsys Tg II is manufactured by Roche Diagnostics.
What is the FDA product code for Elecsys Tg II?
The FDA product code for Elecsys Tg II is MSW.
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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.