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FDA 510(k)

Quantisal Oral Fluid Collection Device

K-Number: K200801 · 2020-07-28

ApplicantImmunalysis Corporation
Decision Date2020-07-28
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 2020-07-28 under approval number K200801. 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 2020-07-28. It is manufactured by Immunalysis Corporation. The 510(k) number is K200801.

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

Quantisal Oral Fluid Collection Device received FDA 510(k) clearance on 2020-07-28, under approval number K200801.

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

PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)

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Related Devices (Code: PJD)

K183048Quantisal II Oral Fluid Collection DeviceImmunalysis Corporation K232898Quantisal™ Oral Fluid Collection DeviceImmunalysis Corporation K223781Quantisal™ II Oral Fluid Collection DeviceImmunalysis Corporation

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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