Immunotech Corp.
Medical device manufacturer in Westbrook, ME.
40510(k) clearances
0PMA approvals
0recalls
Device types
- GKZ Counter, Differential Cell 6
- CDP Radioimmunoassay, Total Triiodothyronine 3
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 3
- KXT Enzyme Immunoassay, Digoxin 2
- CDX Radioimmunoassay, Total Thyroxine 2
- CEE Radioimmunoassay, Thyroxine-Binding Globulin 2
- CGI Radioimmunoassay, Estriol 2
- KLS Enzyme Immunoassay, Theophylline 2
- DLZ Enzyme Immunoassay, Phenobarbital 1
- CDA Acid, Nitrous And Nitrosonaphthol… 1
- DJG Enzyme Immunoassay, Opiates 1
- DIP Enzyme Immunoassay, Diphenylhydantoin 1
- DIO Enzyme Immunoassay, Cocaine And Cocaine… 1
- JXM Enzyme Immunoassay, Benzodiazepine 1
- LBS Ldl & Vldl Precipitation, Cholesterol Via… 1
- CHH Enzymatic Esterase--Oxidase, Cholesterol 1
- KHQ Radioassay, Triiodothyronine Uptake 1
- KLI Enzyme Immunoassay, Non-Radiolabeled, Total… 1
- CGR Radioimmunoassay, Cortisol 1
- KWW Radioimmunoassay, Cholyglycine, Bile Acids 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K954188 | Opticlone IGG1 FITC/IGG2A Pe Isotypic ControlGKZ · Traditional | 11/03/1995SE |
| K946335 | Opticlone(Tm CD3 FITC/CD19 Pe Monoclonal AntibodiesGKZ · Traditional | 10/20/1995SE |
| K953498 | Opticlone IGG1 FITC/IGG1 Pe Isotypic ControlGKZ · Traditional | 09/08/1995SE |
| K952789 | Opticlone CD4FITC/CD8 Pe Monoclonal AntibodiesGKZ · Traditional | 08/14/1995SE |
| K952182 | Opticlone CD3/CD8 Monoclonal AntibodiesGKZ · Traditional | 07/05/1995SE |
| K950626 | Opticlone CD3/CD4 Monoclonal AntibodiesGKZ · Traditional | 05/05/1995SE |
| K931228 | Progesterone Radioimmunoassay KitJLS · Traditional | 10/22/1993SE |
| K911634 | Microzyme(Tm) Free T4 Enzyme Immunoassay TestCEC · Traditional | 06/24/1991SE |
| K911153 | Microzyme Phencyclidine Enzyme Immunoassay Test KTLCM · Traditional | 06/18/1991SE |
| K910411 | Microzyme TSH Enzyme Immunoassay KitJLW · Traditional | 04/03/1991SE |
| K905777 | Microzyme Thyroid Uptake Enzyme Immunoassay KitCEE · Traditional | 01/30/1991SE |
| K903993 | Microzyme(Tm) Methamphet/Amphet Enzyme Immuno KitDKZ · Traditional | 12/20/1990SE |
| K904820 | Microzyme T3 Enzyme Immunoassay KitCDP · Traditional | 12/18/1990SE |
| K904635 | Microzyme THC Enzyme Immunoassay Test KitLDJ · Traditional | 11/01/1990SE |
| K903725 | Ez-Bead TSH Enzyme Immunoassay KitJLW · Traditional | 10/26/1990SE |
| K903609 | Serotonin Enzyme ImmunoassayCDA · Traditional | 10/22/1990SE |
| K903359 | Microzyme Unconjugated Estriol Enzyme Immuno KitCGI · Traditional | 08/22/1990SE |
| K902922 | Microzyme T4 Enzyme Immunoassay KitCDX · Traditional | 07/27/1990SE |
| K902194 | Micro Dau Opiate Enzyme Immunoassay KitDJG · Traditional | 07/17/1990SE |
| K901080 | Ez-Bead Phenytoin Enzyme Immunoassay KitDIP · Traditional | 05/17/1990SE |
| K896781 | Micro Dau Cocaine Metabolite Test KitDIO · Traditional | 03/23/1990SE |
| K896780 | Micro Dau Benzodiazepine Enzyme Immunoassay KitJXM · Traditional | 03/23/1990SE |
| K900036 | Immunotech Hdl-Cholesterol TestLBS · Traditional | 03/09/1990SE |
| K897036 | Immunotech Cholesterol TestCHH · Traditional | 03/06/1990SE |
| K893843 | Ez-Bead Digoxin Eia KitKXT · Traditional | 09/28/1989SE |
| K881257 | Ez-Bead Theophylline Enzyme Immunoassay KitKLS · Traditional | 05/27/1988SE |
| K872172 | Immubead Thyroid UptakeKHQ · Traditional | 08/17/1987SE |
| K872192 | Immubead T4 Enzyme Immunoassay KitKLI · Traditional | 08/13/1987SE |
| K872191 | Immubead T3 Enzyme Immunoassay KitCDP · Traditional | 08/13/1987SE |
| K852995 | Endab PhenobarbitalDLZ · Traditional | 08/12/1985SE |
| K851980 | Endab TSHJLW · Traditional | 05/31/1985SE |
| K840902 | Endab Estriol UnconjugatedCGI · Traditional | 04/18/1984SE |
| K834049 | Endab T3CDP · Traditional | 01/30/1984SE |
| K822684 | Endab Thyroid UptakeCEE · Traditional | 10/08/1982SE |
| K821141 | Endab T4 Enzyme Immunoassay KitCDX · Traditional | 05/13/1982SE |
| K812054 | Endab Digoxin KitKXT · Traditional | 08/12/1981SE |
| K810192 | Endab Cortisol KitCGR · Traditional | 02/06/1981SE |
| K803296 | Endab Cholylglycine Enzyme Immuno. KitKWW · Traditional | 01/16/1981SE |
| K802461 | Endab Digitoxin Enzyme Immunoassay KitLCW · Traditional | 10/31/1980SE |
| K802066 | Endab Theophylline Enzyme ImmunoassayKLS · Traditional | 10/23/1980SE |