FDA 510(k)

Quantisal II Oral Fluid Collection Device

K-Number: K223781 · 2023-07-28

Decision Date2023-07-28

Product CodePJD

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Quantisal II Oral Fluid Collection Device is a medical device manufactured by Immunalysis Corporation. It received FDA 510(k) clearance on 2023-07-28 under approval number K223781. 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 II Oral Fluid Collection Device?

Quantisal II Oral Fluid Collection Device is a medical device that received FDA 510(k) clearance on 2023-07-28. It is manufactured by Immunalysis Corporation. The 510(k) number is K223781.

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

Quantisal II Oral Fluid Collection Device received FDA 510(k) clearance on 2023-07-28, under approval number K223781.

What company makes Quantisal II Oral Fluid Collection Device?

Quantisal II Oral Fluid Collection Device is manufactured by Immunalysis Corporation.

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

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

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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.