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FDA 510(k)

Quantisal II Oral Fluid Collection Device

K-Number: K183048 · 2019-07-29

ApplicantImmunalysis Corporation
Decision Date2019-07-29
Product CodePJD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Quantisal II Oral Fluid Collection Device is the device name listed in this FDA 510(k) record. The listed applicant is Immunalysis Corporation. It received FDA 510(k) clearance on 2019-07-29 under 510(k) number K183048. 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 2019-07-29. The listed applicant is Immunalysis Corporation. The 510(k) number is K183048.

When did Quantisal II Oral Fluid Collection Device receive FDA 510(k) clearance?

Quantisal II Oral Fluid Collection Device received FDA 510(k) clearance on 2019-07-29, under 510(k) number K183048.

Who is the listed applicant for Quantisal II Oral Fluid Collection Device?

The FDA 510(k) record lists Immunalysis Corporation as the applicant. This does not by itself establish the device manufacturer.

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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Other records listing Immunalysis Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252520SEFRIA™ Hydrocodone Oral FluidK232898Quantisal™ Oral Fluid Collection DeviceK223781Quantisal™ II Oral Fluid Collection DeviceK203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayK203564SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassayK203489SEFRIA PCP Oral Fluid Enzyme Immunoassay

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Related Devices (Code: PJD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232898Quantisal™ Oral Fluid Collection DeviceImmunalysis CorporationK223781Quantisal™ II Oral Fluid Collection DeviceImmunalysis CorporationK200801Quantisal 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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