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FDA 510(k)

SEFRIA™ Hydrocodone Oral Fluid

K-Number: K252520 · 2025-09-11

ApplicantImmunalysis Corporation
Decision Date2025-09-11
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SEFRIA™ Hydrocodone Oral Fluid is the device name listed in this FDA 510(k) record. The listed applicant is Immunalysis Corporation. It received FDA 510(k) clearance on 2025-09-11 under 510(k) number K252520. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEFRIA™ Hydrocodone Oral Fluid?

SEFRIA™ Hydrocodone Oral Fluid is a medical device that received FDA 510(k) clearance on 2025-09-11. The listed applicant is Immunalysis Corporation. The 510(k) number is K252520.

When did SEFRIA™ Hydrocodone Oral Fluid receive FDA 510(k) clearance?

SEFRIA™ Hydrocodone Oral Fluid received FDA 510(k) clearance on 2025-09-11, under 510(k) number K252520.

Who is the listed applicant for SEFRIA™ Hydrocodone Oral Fluid?

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 SEFRIA™ Hydrocodone Oral Fluid?

The FDA product code for SEFRIA™ Hydrocodone Oral Fluid is DJG.

Other records listing Immunalysis Corporation as applicant

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Related Devices (Code: DJG)

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.

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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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