Immunalysis Corporation
Medical device manufacturer in Pomona, CA.
50510(k) clearances
0PMA approvals
0recalls
Device types
- DJG Enzyme Immunoassay, Opiates 11
- LAT Radioimmunoassay, Cannabinoid(S) 7
- PJD Oral Fluid Drugs Of Abuse And Alcohol Test… 4
- LCM Enzyme Immunoassay, Phencyclidine 3
- DIO Enzyme Immunoassay, Cocaine And Cocaine… 3
- LAF Gas Chromatography, Methamphetamine 3
- LCL Radioimmunoassay, Phencyclidine 2
- KLN Radioimmunoassay, Cocaine Metabolite 2
- DKZ Enzyme Immunoassay, Amphetamine 2
- DOE Radioimmunoassay, Morphine (125-I), Goat… 1
- QBK Meprobamate Test System 1
- DIS Enzyme Immunoassay, Barbiturate 1
- JXM Enzyme Immunoassay, Benzodiazepine 1
- DJR Enzyme Immunoassay, Methadone 1
- LDJ Enzyme Immunoassay, Cannabinoids 1
- DJP Radioimmunoassay, Amphetamine 1
- JLS Radioimmunoassay, Progesterone 1
- JKC Radioimmunoassay, Dehydroepiandrosterone… 1
- CGJ Radioimmunoassay, Follicle-Stimulating… 1
- CEP Radioimmunoassay, Luteinizing Hormone 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252520 | SEFRIA Hydrocodone Oral FluidDJG · Traditional | 09/11/2025SE |
| K232898 | Quantisal Oral Fluid Collection DevicePJD · Traditional | 11/21/2023SE |
| K223781 | Quantisal II Oral Fluid Collection DevicePJD · Traditional | 07/28/2023SE |
| K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayLAF · Traditional | 12/22/2021SE |
| K203564 | SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassayDJG · Traditional | 12/22/2021SE |
| K203489 | SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM · Traditional | 04/20/2021SE |
| K200801 | Quantisal Oral Fluid Collection DevicePJD · Traditional | 07/28/2020SE |
| K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIAQBK · Traditional | 11/15/2019SE |
| K183048 | Quantisal II Oral Fluid Collection DevicePJD · Traditional | 07/29/2019SE |
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM · Traditional | 01/24/2019SE |
| K181553 | Immunalysis Ethyl Alcohol Enzyme AssayDIC · Traditional | 10/31/2018SE |
| K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine…DJG · Traditional | 06/14/2017SE |
| K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsDIS · Traditional | 10/14/2016SE |
| K153693 | Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLAF · Traditional | 03/18/2016SE |
| K151771 | Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsJXM · Traditional | 01/05/2016SE |
| K152176 | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLCM · Traditional | 09/04/2015SE |
| K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators…DJR · Traditional | 07/24/2015SE |
| K150925 | Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine…DIO · Traditional | 06/29/2015SE |
| K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators…LDJ · Traditional | 06/05/2015SE |
| K143502 | Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300…DJG · Traditional | 05/20/2015SE |
| K150275 | Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine…DJG · Traditional | 03/09/2015SE |
| K141803 | Immunalysis Tramadol Urine Enzyme ImmunoassayDJG · Traditional | 02/12/2015SE |
| K143500 | Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine…DKZ · Traditional | 02/06/2015SE |
| K141406 | Immunalysis Buprenorphine Urine Enzyme Immunoassay, Immunalysis Buprenorphine Urine…DJG · Traditional | 07/01/2014SE |
| K131168 | Immunalysis Oxycodone Enzyme ImmunoassayDJG · Traditional | 01/17/2014SE |
| K051578 | Immunalysis Cocaine/Cocaine Metabolite Elisa for Oral FluidsDIO · Traditional | 11/18/2005SE |
| K051579 | Immunalysis Amphetamine Elisa for Oral FluidsDKZ · Traditional | 10/21/2005SE |
| K051626 | Immunalysis Opiates Elisa for Oral FluidsDJG · Traditional | 10/13/2005SE |
| K051577 | Immunalysis Methamphetamine Elisa for Oral FluidsLAF · Traditional | 10/04/2005SE |
| K050465 | Immunalysis Cocaine Elisa for HairDIO · Traditional | 08/04/2005SE |
| K933572 | Urine Heroin/Morphine Direct Ria Kit (I-125)DOE · Traditional | 04/06/1994SE |
| K913864 | PCP Direct Ria Kit (I-125)LCL · Traditional | 10/11/1991SE |
| K913866 | Urine Amphetamine Direct Ria Kit (I-125)DJP · Traditional | 09/25/1991SE |
| K913867 | Urine Cocaine Metabolite Direct Ria Kit (I-125)KLN · Traditional | 09/19/1991SE |
| K913863 | Urine Heroin/Morphine Direct Ria Kit (I-125)DJG · Traditional | 09/19/1991SE |
| K913865 | Urine THC Direct Ria Kit (I-125)LAT · Traditional | 09/18/1991SE |
| K871549 | Resub. Urine Cocaine Meta. Direct Ria Kit [I-125]KLN · Traditional | 06/16/1987SE |
| K871698 | Resubmission of Urine Heroin/Morphine Kit [I-125]DJG · Traditional | 06/15/1987SE |
| K843534 | Oral Thc-Cannabinoids Direct Ria KitLAT · Traditional | 10/30/1984SE |
| K833911 | Urine THC Cannabinoids Direct Ria KitLAT · Traditional | 01/24/1984SE |
| K821965 | Oral Thc-Cannabinoids Direct Ria KitLAT · Traditional | 07/20/1982SE |
| K820903 | Thc-Cannabinoids Direct Urine Ria KitLAT · Traditional | 05/05/1982SE |
| K811907 | Progesterone Direct Ria Kit (125I)JLS · Traditional | 07/23/1981SE |
| K811906 | Dhea-Sulfate Direct Ria KIT(125I)JKC · Traditional | 07/23/1981SE |
| K811905 | Follicle Stimulating Hormone Direct RiaCGJ · Traditional | 07/23/1981SE |
| K811024 | Luteinizing Hormone Direct Ria Kit 125/ICEP · Traditional | 05/08/1981SE |
| K800514 | Phencyclidine Direct Blood Ria KitLCL · Traditional | 03/19/1980SE |
| K791649 | Tetrahydrocannalbinol Direct Blood KitLAT · Traditional | 10/11/1979SE |
| K781546 | Direct Estriol Ria KitCGI · Traditional | 12/04/1978SE |
| K781048 | THC Direct Ria KitLAT · Traditional | 10/03/1978SE |