Company · US
Immunalysis Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2025. Name variants (Inc, Corp, punctuation) are merged.
50510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 11 |
| LAT | Radioimmunoassay, Cannabinoid(S) | 7 |
| PJD | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device | 4 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 3 |
| LAF | Gas Chromatography, Methamphetamine | 3 |
| LCM | Enzyme Immunoassay, Phencyclidine | 3 |
| DKZ | Enzyme Immunoassay, Amphetamine | 2 |
| KLN | Radioimmunoassay, Cocaine Metabolite | 2 |
| LCL | Radioimmunoassay, Phencyclidine | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| CGI | Radioimmunoassay, Estriol | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | 1 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 |
| DJP | Radioimmunoassay, Amphetamine | 1 |
| DJR | Enzyme Immunoassay, Methadone | 1 |
| DOE | Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. | 1 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2025 | K252520 | SEFRIA Hydrocodone Oral Fluid Immunalysis Corporation | DJG |
| Nov 21, 2023 | K232898 | Quantisal Oral Fluid Collection Device Immunalysis Corporation | PJD |
| Jul 28, 2023 | K223781 | Quantisal II Oral Fluid Collection Device Immunalysis Corporation | PJD |
| Dec 22, 2021 | K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay Immunalysis Corporation | LAF |
| Dec 22, 2021 | K203564 | SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay Immunalysis Corporation | DJG |
| Apr 20, 2021 | K203489 | SEFRIA PCP Oral Fluid Enzyme Immunoassay Immunalysis Corporation | LCM |
| Jul 28, 2020 | K200801 | Quantisal Oral Fluid Collection Device Immunalysis Corporation | PJD |
| Nov 15, 2019 | K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA Immunalysis Corporation | QBK |
| Jul 29, 2019 | K183048 | Quantisal II Oral Fluid Collection Device Immunalysis Corporation | PJD |
| Jan 24, 2019 | K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay Immunalysis Corporation | LCM |
| Oct 31, 2018 | K181553 | Immunalysis Ethyl Alcohol Enzyme Assay Immunalysis Corporation | DIC |
| Jun 14, 2017 | K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators Immunalysis Corporation | DJG |
| Oct 14, 2016 | K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators Immunalysis Corporation | DIS |
| Mar 18, 2016 | K153693 | Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators Immunalysis Corporation | LAF |
| Jan 5, 2016 | K151771 | Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators Immunalysis Corporation | JXM |
| Sep 4, 2015 | K152176 | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators Immunalysis Corporation | LCM |
| Jul 24, 2015 | K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control S Immunalysis Corporation | DJR |
| Jun 29, 2015 | K150925 | Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoyl Immunalysis Corporation | DIO |
| Jun 5, 2015 | K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Se Immunalysis Corporation | LDJ |
| May 20, 2015 | K143502 | Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calib Immunalysis Corporation | DJG |
| Mar 9, 2015 | K150275 | Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acet Immunalysis Corporation | DJG |
| Feb 12, 2015 | K141803 | IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY Immunalysis Corporation | DJG |
| Feb 6, 2015 | K143500 | Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urin Immunalysis Corporation | DKZ |
| Jul 1, 2014 | K141406 | IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS Immunalysis Corporation | DJG |
| Jan 17, 2014 | K131168 | IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY Immunalysis Corporation | DJG |
| Nov 18, 2005 | K051578 | IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS Immunalysis Corporation | DIO |
| Oct 21, 2005 | K051579 | IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS Immunalysis Corporation | DKZ |
| Oct 13, 2005 | K051626 | IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS Immunalysis Corporation | DJG |
| Oct 4, 2005 | K051577 | IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS Immunalysis Corporation | LAF |
| Aug 4, 2005 | K050465 | IMMUNALYSIS COCAINE ELISA FOR HAIR Immunalysis Corporation | DIO |
| Apr 6, 1994 | K933572 | URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) Immunalysis Corporation | DOE |
| Oct 11, 1991 | K913864 | PCP DIRECT RIA KIT (I-125) Immunalysis Corporation | LCL |
| Sep 25, 1991 | K913866 | URINE AMPHETAMINE DIRECT RIA KIT (I-125) Immunalysis Corporation | DJP |
| Sep 19, 1991 | K913867 | URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) Immunalysis Corporation | KLN |
| Sep 19, 1991 | K913863 | URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) Immunalysis Corporation | DJG |
| Sep 18, 1991 | K913865 | URINE THC DIRECT RIA KIT (I-125) Immunalysis Corporation | LAT |
| Jun 16, 1987 | K871549 | RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] Immunalysis Corporation | KLN |
| Jun 15, 1987 | K871698 | RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125] Immunalysis Corporation | DJG |
| Oct 30, 1984 | K843534 | ORAL THC-CANNABINOIDS DIRECT RIA KIT Immunalysis Corporation | LAT |
| Jan 24, 1984 | K833911 | URINE THC CANNABINOIDS DIRECT RIA KIT Immunalysis Corporation | LAT |
| Jul 20, 1982 | K821965 | ORAL THC-CANNABINOIDS DIRECT RIA KIT Immunalysis Corporation | LAT |
| May 5, 1982 | K820903 | THC-CANNABINOIDS DIRECT URINE RIA KIT Immunalysis Corporation | LAT |
| Jul 23, 1981 | K811907 | PROGESTERONE DIRECT RIA KIT (125I) Immunalysis Corporation | JLS |
| Jul 23, 1981 | K811906 | DHEA-SULFATE DIRECT RIA KIT(125I) Immunalysis Corporation | JKC |
| Jul 23, 1981 | K811905 | FOLLICLE STIMULATING HORMONE DIRECT RIA Immunalysis Corporation | CGJ |
| May 8, 1981 | K811024 | LUTEINIZING HORMONE DIRECT RIA KIT 125/I Immunalysis Corporation | CEP |
| Mar 19, 1980 | K800514 | PHENCYCLIDINE DIRECT BLOOD RIA KIT Immunalysis Corporation | LCL |
| Oct 11, 1979 | K791649 | TETRAHYDROCANNALBINOL DIRECT BLOOD KIT Immunalysis Corporation | LAT |
| Dec 4, 1978 | K781546 | DIRECT ESTRIOL RIA KIT Immunalysis Corporation | CGI |
| Oct 3, 1978 | K781048 | THC DIRECT RIA KIT Immunalysis Corporation | LAT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||