Leeco Diagnostics, Inc.
Medical device manufacturer in Southfield, MI.
49510(k) clearances
0PMA approvals
0recalls
Device types
- JHI Visual, Pregnancy Hcg, Prescription Use 10
- CDZ Radioimmunoassay, Testosterones And… 4
- CEP Radioimmunoassay, Luteinizing Hormone 4
- GTZ Antisera, All Groups, Streptococcus Spp. 3
- CFT Radioimmunoassay, Prolactin (Lactogen) 3
- DHA System, Test, Human Chorionic Gonadotropin 2
- LCX Kit, Test, Pregnancy, Hcg, Over The Counter 2
- CDP Radioimmunoassay, Total Triiodothyronine 2
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 2
- CGJ Radioimmunoassay, Follicle-Stimulating… 2
- JFH Acid Phosphatase (Prostatic), Tartrate… 2
- LCP Assay, Glycosylated Hemoglobin 2
- DBF Ferritin, Antigen, Antiserum, Control 1
- CDX Radioimmunoassay, Total Thyroxine 1
- KHQ Radioassay, Triiodothyronine Uptake 1
- DGC Ige, Antigen, Antiserum, Control 1
- CHP Radioimmunoassay, Estradiol 1
- CGR Radioimmunoassay, Cortisol 1
- JLS Radioimmunoassay, Progesterone 1
- KTN System, Test, Infectious Mononucleosis 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K895765 | Leeco Preview(R) Ebv (Eia)KTN · Traditional | 10/31/1989SE |
| K894122 | Leeco Vis-Disk Strep-A (Eia)GTZ · Traditional | 08/15/1989SE |
| K891096 | Vis-Disk HCG (Eia) JPL-041MDHA · Traditional | 06/16/1989SE |
| K891095 | Vis-Disk HCG (Eia) Lyophilized JPL-044MDHA · Traditional | 06/16/1989SE |
| K883269 | Prl-QuantCFT · Traditional | 09/13/1988SE |
| K880577 | CONCEP-7-BHCGJHI · Traditional | 03/15/1988SE |
| K880069 | Leeco Pregnastick (Eia) Catalog #003LCX · Traditional | 02/11/1988SE |
| K870259 | Vis-Cube HCG (Eia) Lyophilized JPL-044JHI · Traditional | 03/10/1987SE |
| K864170 | Leeco Vis-Cube Strep a (Eia)GTZ · Traditional | 02/03/1987SE |
| K863999 | Vis-Cube Pregnancy Home Test,Cat. # JPL-042LCX · Traditional | 01/09/1987SE |
| K863933 | Vis-Cube HCG (Eia)JHI · Traditional | 12/15/1986SE |
| K861354 | Right-Day Ovulation Home TestCEP · Traditional | 09/16/1986SE |
| K861703 | Leeco CONCEP-7-BHCG (Eia) II (Modified)JHJ · Traditional | 07/29/1986SE |
| K860538 | Right-Day Urinary LH (Eia)CEP · Traditional | 07/29/1986SE |
| K861945 | Lee-Bead Prolactin (Eia)CFT · Traditional | 06/13/1986SE |
| K860947 | Leeco-Screen, Strep a (Eia)GTZ · Traditional | 05/13/1986SE |
| K860003 | Leeco Testosterone Diagnostic KitCDZ · Traditional | 03/17/1986SE |
| K854837 | Lee-Bead Beta FSH (Eia)CGJ · Traditional | 01/13/1986SE |
| K854838 | Lee-Bead Beta LH (Eia)CEP · Traditional | 01/07/1986SE |
| K853977 | Beta-Tsh-IrmaJLW · Traditional | 10/22/1985SE |
| K850531 | Leeco CONCEP-7-BHCG EiaJHI · Traditional | 04/02/1985SE |
| K850530 | Leeco CONCEP-7-BHCG IrmaJHI · Traditional | 04/02/1985SE |
| K850201 | Leeco CONCEP-7-BHCG Leiad IIJHI · Traditional | 03/04/1985SE |
| K850056 | Leeco Progesterone-Quant Diagnostic Test KitJLS · Traditional | 02/06/1985SE |
| K844153 | CONCEP-7-BHCG (Eia)JHI · Traditional | 12/14/1984SE |
| K843384 | Leeco Cortisol-QuantCGR · Traditional | 09/28/1984SE |
| K834586 | Leeco E2 Quant Diag. Test KitCHP · Traditional | 03/09/1984SE |
| K834348 | Leeco T3-QUANT Diag. KitCDP · Traditional | 02/21/1984SE |
| K831208 | Ige-Quant Diagnostic Test KitDGC · Traditional | 05/09/1983SE |
| K830808 | Leeco T3-RIA Diagnostic KitCDP · Traditional | 04/08/1983SE |
| K830785 | Leeco Dig-Quant Diag. Test Kit · Traditional | 04/08/1983SE |
| K830512 | Leeco Testosterone Diagnostic KitCDZ · Traditional | 04/05/1983SE |
| K822575 | Leeco T3% Diagnostic KitKHQ · Traditional | 09/30/1982SE |
| K822399 | Leeco T4 Quant Diagnostics Test KitCDX · Traditional | 09/13/1982SE |
| K820039 | Leeco Prl-Quant Diagnostic Test KitCFT · Traditional | 01/22/1982SE |
| K813392 | Radioimmunoassay for Human ThyroidJLW · Traditional | 12/22/1981SE |
| K813059 | Leeco Testo-Quant Diag. KitCDZ · Traditional | 11/16/1981SE |
| K812156 | CONCEP-7-BHCGJHI · Traditional | 08/20/1981SE |
| K811880 | Leeco Ferritin-Quant Diag. Test KitDBF · Traditional | 07/16/1981SE |
| K810662 | Leeco Lh-Quant Diagnostic KitCEP · Traditional | 03/31/1981SE |
| K810663 | Leeco Fsh-Quant Diagnostic KitCGJ · Traditional | 03/27/1981SE |
| K810232 | Leeco P.A.P. - Quant Diagnostic KitJFH · Traditional | 02/10/1981SE |
| K803001 | Leeco Testo-Quant Diagnostic KitCDZ · Traditional | 01/02/1981SE |
| K801289 | Leeco Glyco-Hemoglobin Diag. Test KitLCP · Traditional | 06/30/1980SE |
| K792652 | Leeco P.A.P. Quant. Diagnostic KitJFH · Traditional | 01/16/1980SE |
| K792308 | CONCEP-7-BHCGJHI · Traditional | 12/06/1979SE |
| K791103 | Leeco Glyco-Hemoglobin Diagnostic KitLCP · Traditional | 06/28/1979SE |
| K790397 | CONCEP-7-B-HCGJHI · Traditional | 05/23/1979SE |
| K782159 | Diagnostic Kit, FERRITAB-FE-59JJA · Traditional | 02/01/1979SE |