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FDA 510(k)

Elecsys Anti-TSHR

K-Number: K193313 · 2020-02-27

ApplicantRoche Diagnostics
Decision Date2020-02-27
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Elecsys Anti-TSHR is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2020-02-27 under approval number K193313. 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-TSHR?

Elecsys Anti-TSHR is a medical device that received FDA 510(k) clearance on 2020-02-27. It is manufactured by Roche Diagnostics. The 510(k) number is K193313.

When was Elecsys Anti-TSHR approved by the FDA?

Elecsys Anti-TSHR received FDA 510(k) clearance on 2020-02-27, under approval number K193313.

What company makes Elecsys Anti-TSHR?

Elecsys Anti-TSHR is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys Anti-TSHR?

The FDA product code for Elecsys Anti-TSHR 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.

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