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FDA 510(k)

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument

K-Number: K232286 · 2023-12-20

ApplicantQuidel Corporation
Decision Date2023-12-20
Product CodePGI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2023-12-20 under approval number K232286. The device is classified under product code PGI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument?

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument is a medical device that received FDA 510(k) clearance on 2023-12-20. It is manufactured by Quidel Corporation. The 510(k) number is K232286.

When was Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument approved by the FDA?

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument received FDA 510(k) clearance on 2023-12-20, under approval number K232286.

What company makes Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument?

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument is manufactured by Quidel Corporation.

What is the FDA product code for Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument?

The FDA product code for Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument is PGI.

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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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