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FDA 510(k)

Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay

K-Number: K181135 · 2019-01-24

ApplicantImmunalysis Corporation
Decision Date2019-01-24
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is a medical device manufactured by Immunalysis Corporation. It received FDA 510(k) clearance on 2019-01-24 under approval number K181135. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay?

Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2019-01-24. It is manufactured by Immunalysis Corporation. The 510(k) number is K181135.

When was Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay approved by the FDA?

Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay received FDA 510(k) clearance on 2019-01-24, under approval number K181135.

What company makes Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay?

Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is manufactured by Immunalysis Corporation.

What is the FDA product code for Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay?

The FDA product code for Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is LCM.

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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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