Electro-Nucleonics Laboratories, Inc.
Medical device manufacturer in Columbia, MD.
41510(k) clearances
0PMA approvals
0recalls
Device types
- JJE Analyzer, Chemistry (Photometric… 3
- JQW Station, Pipetting And Diluting, For… 3
- DHN Antinuclear Antibody, Indirect… 2
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 2
- KLS Enzyme Immunoassay, Theophylline 2
- LJB Enzyme Linked Immunoabsorbent Assay… 1
- GRA Antiserum, Fluorescent, Mumps Virus 1
- GRE Antiserum, Fluorescent, Rubeola 1
- LFN Nephelometric Inhibition Immunoassay… 1
- LCR Fluorescent Immunoassay, Tobramycin 1
- GPW Antigen, Cf, Psittacosis (Chlamydia Group) 1
- DIP Enzyme Immunoassay, Diphenylhydantoin 1
- LCD Enzyme Immunoassay, Gentamicin 1
- JJG Analyzer, Chemistry, Centrifugal, For… 1
- GNP Antiserum, Cf, Epstein-Barr Virus 1
- GGW Test, Time, Partial Thromboplastin 1
- DEW Igg, Antigen, Antiserum, Control 1
- DAO Igm (Mu Chain Specific), Antigen… 1
- GOK Antisera, Hai (Including Hai Control)… 1
- CZP Iga, Antigen, Antiserum, Control 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K873925 | Virgo(Tm) Measles Igg ElisaLJB · Traditional | 02/24/1988SE |
| K873617 | Gemstar II SystemJJE · Traditional | 10/19/1987SE |
| K873416 | Multi-Access Reagent DispenserJQW · Traditional | 10/09/1987SE |
| K873358 | Gemeni Uric Acid U.V.CDO · Traditional | 09/11/1987SE |
| K873088 | Virgo(Tm) Rubella Igg ElisaLFX · Traditional | 09/09/1987SE |
| K871905 | Toxoplasma Gondii Igg ElisaLGD · Traditional | 07/30/1987SE |
| K870928 | Cholesterol (Total) Analysis ProductsCHH · Traditional | 04/22/1987SE |
| K863874 | Lipase Hydrolysis/Glycerol Kinase, TriglyceridesCDT · Traditional | 11/13/1986SE |
| K862640 | Amylase LTSCJA · Traditional | 09/09/1986SE |
| K853372 | Gemstar Ipa Theophylline Test KitKLS · Traditional | 09/04/1985SE |
| K853373 | Delta Trol I & IIJJT · Traditional | 08/23/1985SE |
| K851267 | Gemeni Ast-Lts ReagentsCIT · Traditional | 04/29/1985SE |
| K843779 | Autoloader IIJQW · Traditional | 01/03/1985SE |
| K844065 | Eni Blood Urea Nitrogen ReagentCDQ · Traditional | 11/27/1984SE |
| K841127 | Virgo Reagents Indirect FluorscentDHN · Traditional | 04/25/1984SE |
| K832744 | StarlyteJGS · Traditional | 11/03/1983SE |
| K832648 | AcclaimJJE · Traditional | 09/20/1983SE |
| K831504 | Herpes Ident. & Typing Test HittGQL · Traditional | 09/20/1983SE |
| K832639 | Alt -LtsCKA · Traditional | 09/12/1983SE |
| K831965 | Creatine Kinase Reagent CK LTSCGS · Traditional | 09/12/1983SE |
| K831924 | Antibody to Respiratory Syncytial VirusLKT · Traditional | 08/11/1983SE |
| K822826 | Antibody to Mumps Virus Ifa TestGRA · Traditional | 12/03/1982SE |
| K821249 | Eni Antibody to Measles(Rubeola) VirusGRE · Traditional | 07/30/1982SE |
| K821335 | Gemstar SystemJJE · Traditional | 07/13/1982SE |
| K821544 | Detection of TheophyllineKLS · Traditional | 06/10/1982SE |
| K821543 | Ipa for Detection of PhenobarbitalLFN · Traditional | 06/03/1982SE |
| K821542 | Virgo Immuno-Precipitation Assay TobraLCR · Traditional | 06/03/1982SE |
| K811570 | Antibody to Chlamydia TrachomatisGPW · Traditional | 07/23/1981SE |
| K811745 | Virgo Ipa for Detection of PhenytoinDIP · Traditional | 07/10/1981SE |
| K811744 | Virgo Ipa for Detection of GentamicinLCD · Traditional | 07/10/1981SE |
| K811525 | Flexigram Auto Loader SystemJJG · Traditional | 06/18/1981SE |
| K810860 | Eni Antibody to Epstein-Barr VirusGNP · Traditional | 05/05/1981SE |
| K800787 | Antibody to Varicella-Zoster VirusGGW · Traditional | 07/14/1980SE |
| K801030 | Riause Auto ProcessorJQW · Traditional | 05/28/1980SE |
| K800451 | Gemeni Igg AssayDEW · Traditional | 04/24/1980SE |
| K800450 | Gemeni Igm AssayDAO · Traditional | 04/24/1980SE |
| K792635 | Antibody to Rubella VirusGOK · Traditional | 03/19/1980SE |
| K800449 | Gemeni Iga AssayCZP · Traditional | 03/12/1980SE |
| K791058 | Antibody to Herpesvirus HominisGQO · Traditional | 09/07/1979SE |
| K771376 | Ifa Anti-NdnaDHN · Traditional | 10/18/1977SE |
| K761269 | Gemeni GPT (Alt) AssayCKA · Traditional | 12/29/1976SE |