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 a medical device manufactured by Immunalysis Corporation. It received FDA 510(k) clearance on 2025-09-11 under approval 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. It is manufactured by Immunalysis Corporation. The 510(k) number is K252520.
When was SEFRIA Hydrocodone Oral Fluid approved by the FDA?
SEFRIA Hydrocodone Oral Fluid received FDA 510(k) clearance on 2025-09-11, under approval number K252520.
What company makes SEFRIA Hydrocodone Oral Fluid?
SEFRIA Hydrocodone Oral Fluid is manufactured by Immunalysis Corporation.
What is the FDA product code for SEFRIA Hydrocodone Oral Fluid?
The FDA product code for SEFRIA Hydrocodone Oral Fluid is DJG.
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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.