FDA 510(k) Applications Submitted by IMMUNALYSIS CORPORATION

FDA 510(k) Number Submission Date Device Name Applicant
K800514 03/05/1980 PHENCYCLIDINE DIRECT BLOOD RIA KIT IMMUNALYSIS CORPORATION
K820903 03/31/1982 THC-CANNABINOIDS DIRECT URINE RIA KIT IMMUNALYSIS CORPORATION
K811024 04/15/1981 LUTEINIZING HORMONE DIRECT RIA KIT 125/I IMMUNALYSIS CORPORATION
K781048 06/21/1978 THC DIRECT RIA KIT IMMUNALYSIS CORPORATION
K811905 07/01/1981 FOLLICLE STIMULATING HORMONE DIRECT RIA IMMUNALYSIS CORPORATION
K811906 07/01/1981 DHEA-SULFATE DIRECT RIA KIT(125I) IMMUNALYSIS CORPORATION
K811907 07/01/1981 PROGESTERONE DIRECT RIA KIT (125I) IMMUNALYSIS CORPORATION
K821965 07/02/1982 ORAL THC-CANNABINOIDS DIRECT RIA KIT IMMUNALYSIS CORPORATION
K791649 08/24/1979 TETRAHYDROCANNALBINOL DIRECT BLOOD KIT IMMUNALYSIS CORPORATION
K781546 09/13/1978 DIRECT ESTRIOL RIA KIT IMMUNALYSIS CORPORATION
K833911 11/14/1983 URINE THC CANNABINOIDS DIRECT RIA KIT IMMUNALYSIS CORPORATION
K933572 07/23/1993 URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) IMMUNALYSIS CORPORATION
K913863 08/27/1991 URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) IMMUNALYSIS CORPORATION
K913864 08/27/1991 PCP DIRECT RIA KIT (I-125) IMMUNALYSIS CORPORATION
K913865 08/27/1991 URINE THC DIRECT RIA KIT (I-125) IMMUNALYSIS CORPORATION
K913866 08/27/1991 URINE AMPHETAMINE DIRECT RIA KIT (I-125) IMMUNALYSIS CORPORATION
K913867 08/27/1991 URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) IMMUNALYSIS CORPORATION
K843534 09/07/1984 ORAL THC-CANNABINOIDS DIRECT RIA KIT IMMUNALYSIS CORPORATION
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
K871549 04/14/1987 RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] IMMUNALYSIS CORPORATION
K871698 04/28/1987 RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125] IMMUNALYSIS CORPORATION


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