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FDA 510(k)

SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay

K-Number: K203647 · 2021-12-22

ApplicantImmunalysis Corporation
Decision Date2021-12-22
Product CodeLAF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is a medical device manufactured by Immunalysis Corporation. It received FDA 510(k) clearance on 2021-12-22 under approval number K203647. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay?

SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2021-12-22. It is manufactured by Immunalysis Corporation. The 510(k) number is K203647.

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

SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay received FDA 510(k) clearance on 2021-12-22, under approval number K203647.

What company makes SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay?

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

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

The FDA product code for SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is LAF.

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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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