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Immunalysis Corporation

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories8
Latest FDA decision2025-09-11
TypeNumberDevice NameCodeDateActions
510(k) K252520 SEFRIA™ Hydrocodone Oral FluidDJG2025-09-11 View
510(k) K232898 Quantisal™ Oral Fluid Collection DevicePJD2023-11-21 View
510(k) K223781 Quantisal™ II Oral Fluid Collection DevicePJD2023-07-28 View
510(k) K203564 SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassayDJG2021-12-22 View
510(k) K203647 SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayLAF2021-12-22 View
510(k) K203489 SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM2021-04-20 View
510(k) K200801 Quantisal Oral Fluid Collection DevicePJD2020-07-28 View
510(k) K190397 Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIAQBK2019-11-15 View
510(k) K183048 Quantisal II Oral Fluid Collection DevicePJD2019-07-29 View
510(k) K181135 Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM2019-01-24 View
510(k) K181553 Immunalysis Ethyl Alcohol Enzyme AssayDIC2018-10-31 View
510(k) K161216 Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine CalibratorsDJG2017-06-14 View
510(k) K161714 Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsDIS2016-10-14 View
510(k) K153693 Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLAF2016-03-18 View
510(k) K151771 Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsJXM2016-01-05 View
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