FDA 510(k)

Elecsys HSV-2 IgG (08948887160)

K-Number: K220924 · 2022-10-12

Decision Date2022-10-12

Product CodeMYF

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Elecsys HSV-2 IgG (08948887160) is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2022-10-12 under approval number K220924. The device is classified under product code MYF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys HSV-2 IgG (08948887160)?

Elecsys HSV-2 IgG (08948887160) is a medical device that received FDA 510(k) clearance on 2022-10-12. It is manufactured by Roche Diagnostics. The 510(k) number is K220924.

When was Elecsys HSV-2 IgG (08948887160) approved by the FDA?

Elecsys HSV-2 IgG (08948887160) received FDA 510(k) clearance on 2022-10-12, under approval number K220924.

What company makes Elecsys HSV-2 IgG (08948887160)?

Elecsys HSV-2 IgG (08948887160) is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys HSV-2 IgG (08948887160)?

The FDA product code for Elecsys HSV-2 IgG (08948887160) is MYF.

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Related Devices (Code: MYF)

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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.