Immunalysis Corporation
Pomona, CA, US
Immunalysis Corporation appears in FDA device records in Pomona, CA. FDA records list 50 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 50
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 50 510(k) clearances for Immunalysis Corporation between 1978 and 2025. The busiest year on record is 2015, with 8. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 2 |
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 4 |
| 1982 | 2 |
| 1984 | 2 |
| 1987 | 2 |
| 1991 | 5 |
| 1994 | 1 |
| 2005 | 5 |
| 2014 | 2 |
| 2015 | 8 |
| 2016 | 3 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 3 |
| 2023 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252520 | SEFRIA™ Hydrocodone Oral Fluid | DJG | Substantially Equivalent | |
| K232898 | Quantisal™ Oral Fluid Collection Device | PJD | Substantially Equivalent | |
| K223781 | Quantisal™ II Oral Fluid Collection Device | PJD | Substantially Equivalent | |
| K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay | LAF | Substantially Equivalent | |
| K203564 | SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay | DJG | Substantially Equivalent | |
| K203489 | SEFRIA PCP Oral Fluid Enzyme Immunoassay | LCM | Substantially Equivalent | |
| K200801 | Quantisal Oral Fluid Collection Device | PJD | Substantially Equivalent | |
| K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA | QBK | Substantially Equivalent | |
| K183048 | Quantisal II Oral Fluid Collection Device | PJD | Substantially Equivalent | |
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | LCM | Substantially Equivalent | |
| K181553 | Immunalysis Ethyl Alcohol Enzyme Assay | DIC | Substantially Equivalent | |
| K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators | DJG | Substantially Equivalent | |
| K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | DIS | Substantially Equivalent | |
| K153693 | Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | LAF | Substantially Equivalent | |
| K151771 | Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | JXM | Substantially Equivalent | |
| K152176 | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | LCM | Substantially Equivalent | |
| K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets | DJR | Substantially Equivalent | |
| K150925 | Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set | DIO | Substantially Equivalent | |
| K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set | LDJ | Substantially Equivalent | |
| K143502 | Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls | DJG | Substantially Equivalent | |
| K150275 | Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls | DJG | Substantially Equivalent | |
| K141803 | IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY | DJG | Substantially Equivalent | |
| K143500 | Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set | DKZ | Substantially Equivalent | |
| K141406 | IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS | DJG | Substantially Equivalent | |
| K131168 | IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY | DJG | Substantially Equivalent | |
| K051578 | IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS | DIO | Substantially Equivalent | |
| K051579 | IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS | DKZ | Substantially Equivalent | |
| K051626 | IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS | DJG | Substantially Equivalent | |
| K051577 | IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS | LAF | Substantially Equivalent | |
| K050465 | IMMUNALYSIS COCAINE ELISA FOR HAIR | DIO | Substantially Equivalent | |
| K933572 | URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) | DOE | Substantially Equivalent | |
| K913864 | PCP DIRECT RIA KIT (I-125) | LCL | Substantially Equivalent | |
| K913866 | URINE AMPHETAMINE DIRECT RIA KIT (I-125) | DJP | Substantially Equivalent | |
| K913867 | URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) | KLN | Substantially Equivalent | |
| K913863 | URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) | DJG | Substantially Equivalent | |
| K913865 | URINE THC DIRECT RIA KIT (I-125) | LAT | Substantially Equivalent | |
| K871549 | RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] | KLN | Substantially Equivalent | |
| K871698 | RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125] | DJG | Substantially Equivalent | |
| K843534 | ORAL THC-CANNABINOIDS DIRECT RIA KIT | LAT | Substantially Equivalent | |
| K833911 | URINE THC CANNABINOIDS DIRECT RIA KIT | LAT | Substantially Equivalent | |
| K821965 | ORAL THC-CANNABINOIDS DIRECT RIA KIT | LAT | Substantially Equivalent | |
| K820903 | THC-CANNABINOIDS DIRECT URINE RIA KIT | LAT | Substantially Equivalent | |
| K811907 | PROGESTERONE DIRECT RIA KIT (125I) | JLS | Substantially Equivalent | |
| K811906 | DHEA-SULFATE DIRECT RIA KIT(125I) | JKC | Substantially Equivalent | |
| K811905 | FOLLICLE STIMULATING HORMONE DIRECT RIA | CGJ | Substantially Equivalent | |
| K811024 | LUTEINIZING HORMONE DIRECT RIA KIT 125/I | CEP | Substantially Equivalent | |
| K800514 | PHENCYCLIDINE DIRECT BLOOD RIA KIT | LCL | Substantially Equivalent | |
| K791649 | TETRAHYDROCANNALBINOL DIRECT BLOOD KIT | LAT | Substantially Equivalent | |
| K781546 | DIRECT ESTRIOL RIA KIT | CGI | Substantially Equivalent | |
| K781048 | THC DIRECT RIA KIT | LAT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- LAFGas Chromatography, Methamphetamine
- QBKMeprobamate Test System
- PJDOral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
- DJPRadioimmunoassay, Amphetamine
- LATRadioimmunoassay, Cannabinoid(S)
- KLNRadioimmunoassay, Cocaine Metabolite
- JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- CGIRadioimmunoassay, Estriol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
- LCLRadioimmunoassay, Phencyclidine
- JLSRadioimmunoassay, Progesterone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain