FDA 510(k)

Quantisal Oral Fluid Collection Device

K-Number: K232898 · 2023-11-21

Decision Date2023-11-21

Product CodePJD

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Quantisal Oral Fluid Collection Device is a medical device manufactured by Immunalysis Corporation. It received FDA 510(k) clearance on 2023-11-21 under approval number K232898. The device is classified under product code PJD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quantisal Oral Fluid Collection Device?

Quantisal Oral Fluid Collection Device is a medical device that received FDA 510(k) clearance on 2023-11-21. It is manufactured by Immunalysis Corporation. The 510(k) number is K232898.

When was Quantisal Oral Fluid Collection Device approved by the FDA?

Quantisal Oral Fluid Collection Device received FDA 510(k) clearance on 2023-11-21, under approval number K232898.

What company makes Quantisal Oral Fluid Collection Device?

Quantisal Oral Fluid Collection Device is manufactured by Immunalysis Corporation.

What is the FDA product code for Quantisal Oral Fluid Collection Device?

The FDA product code for Quantisal Oral Fluid Collection Device is PJD.

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Related PubMed Literature

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Related Devices (Code: PJD)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.