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510(k) K252520

SEFRIA™ Hydrocodone Oral Fluid by Immunalysis Corporation — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2025
Date Received
August 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Immunalysis Corporation

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  • K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (December 22, 2021)
  • K203564 — SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay (December 22, 2021)
  • K203489 — SEFRIA PCP Oral Fluid Enzyme Immunoassay (April 20, 2021)
  • K200801 — Quantisal Oral Fluid Collection Device (July 28, 2020)
  • K190397 — Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA (November 15, 2019)
  • K183048 — Quantisal II Oral Fluid Collection Device (July 29, 2019)
  • K181135 — Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (January 24, 2019)
  • K181553 — Immunalysis Ethyl Alcohol Enzyme Assay (October 31, 2018)

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