Elecsys Anti-Tg
K-Number: K222610 · 2023-09-15
ApplicantRoche Diagnostics
Decision Date2023-09-15
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Elecsys Anti-Tg is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2023-09-15 under approval number K222610. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Elecsys Anti-Tg?
Elecsys Anti-Tg is a medical device that received FDA 510(k) clearance on 2023-09-15. It is manufactured by Roche Diagnostics. The 510(k) number is K222610.
When was Elecsys Anti-Tg approved by the FDA?
Elecsys Anti-Tg received FDA 510(k) clearance on 2023-09-15, under approval number K222610.
What company makes Elecsys Anti-Tg?
Elecsys Anti-Tg is manufactured by Roche Diagnostics.
What is the FDA product code for Elecsys Anti-Tg?
The FDA product code for Elecsys Anti-Tg is JZO.
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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.