FDA 510(k) Applications Submitted by Immunalysis Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K150275 02/04/2015 Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls Immunalysis Corporation
K150925 04/06/2015 Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set Immunalysis Corporation
K131168 04/24/2013 IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY Immunalysis Corporation
K161216 04/29/2016 Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators IMMUNALYSIS CORPORATION
K151203 05/05/2015 Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set IMMUNALYSIS CORPORATION
K151395 05/26/2015 Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets Immunalysis Corporation
K141406 05/28/2014 IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS Immunalysis Corporation
K161714 06/21/2016 Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators IMMUNALYSIS CORPORATION
K151771 06/30/2015 Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators IMMUNALYSIS CORPORATION
K141803 07/03/2014 IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY Immunalysis Corporation
K152176 08/04/2015 Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators Immunalysis Corporation
K143500 12/10/2014 Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set Immunalysis Corporation
K143502 12/10/2014 Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls IMMUNALYSIS CORPORATION
K153693 12/23/2015 Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators IMMUNALYSIS CORPORATION
K050465 03/03/2005 IMMUNALYSIS COCAINE ELISA FOR HAIR Immunalysis Corporation
K051577 06/14/2005 IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS Immunalysis Corporation
K051578 06/14/2005 IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS Immunalysis Corporation
K051579 06/14/2005 IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS Immunalysis Corporation
K051626 06/20/2005 IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS Immunalysis Corporation
K223781 12/16/2022 QuantisalÖ II Oral Fluid Collection Device Immunalysis Corporation
K181135 04/30/2018 Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay Immunalysis Corporation
K183048 11/02/2018 Quantisal II Oral Fluid Collection Device Immunalysis Corporation
K203489 11/27/2020 SEFRIA PCP Oral Fluid Enzyme Immunoassay Immunalysis Corporation
K203564 12/07/2020 SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay Immunalysis Corporation
K203647 12/14/2020 SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay Immunalysis Corporation
K200801 03/27/2020 Quantisal Oral Fluid Collection Device Immunalysis Corporation
K181553 06/13/2018 Immunalysis Ethyl Alcohol Enzyme Assay Immunalysis Corporation
K190397 02/19/2019 Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA Immunalysis Corporation


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