Windsor Laboratories, Inc.
Medical device manufacturer in Garland, TX.
19510(k) clearances
0PMA approvals
0recalls
Device types
- JIS Calibrator, Primary 4
- DLJ Calibrators, Drug Specific 4
- JSX Kit, Identification, Neisseria Gonorrhoeae 1
- LER Fluorescent Immunoassay, Theophylline 1
- LGR Fluorescence Polarization Immunoassay… 1
- LCQ Fluorescent Immunoassay Gentamicin 1
- LFW Fluorescence Polarization Immunoassay… 1
- LGJ Fluorescence Polarization Immunoassay… 1
- LGQ Fluorescence Polarization Immunoassay… 1
- KXT Enzyme Immunoassay, Digoxin 1
- JJF Analyzer, Chemistry, Micro, For Clinical Use 1
- KLT Enzyme Immunoassay, Carbamazepine 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K873281 | Carbamazepine (Fpia) Calibrator KitDLJ · Traditional | 10/28/1987SE |
| K873282 | Carbamazepine Fpia Fluores. Polariza. ImmunoassayKLT · Traditional | 09/22/1987SE |
| K871486 | (Fpia) Assay BufferJJF · Traditional | 05/08/1987SE |
| K870390 | Phenobarbital (Fpia) Calibrator KitDLJ · Traditional | 04/01/1987SE |
| K870389 | Digoxin (Fpia) Calibrator KitDLJ · Traditional | 04/01/1987SE |
| K864333 | Digoxin Fpia Fluorescence Polarization ImmunoassayKXT · Traditional | 01/05/1987SE |
| K863625 | Phenobarbital-Fpia Fluores. Polar. Immunoassay KitLGQ · Traditional | 11/10/1986SE |
| K863244 | Amikacin (Fpia) Calibrator KitDLJ · Traditional | 08/29/1986SE |
| K862248 | Amikacin Kit (Fpia)LGJ · Traditional | 08/04/1986SE |
| K861891 | Tobramycin (Fpia) Calibrator KitJIS · Traditional | 06/25/1986SE |
| K861770 | Phenytoin (Fpia) Calibrator KitJIS · Traditional | 06/25/1986SE |
| K861769 | Gentamicin (Fpia) Calibrator KitJIS · Traditional | 06/25/1986SE |
| K861768 | Theophylline (Fpia) Calibrator KitJIS · Traditional | 06/25/1986SE |
| K854392 | Tobramycin Kit(Fpia)Fluorescence Polarization ImmuLFW · Traditional | 12/05/1985SE |
| K852013 | Gentamicin Kit(Fpia)LCQ · Traditional | 06/10/1985SE |
| K842586 | Phenytoin Kit Fluorescence PolarizationLGR · Traditional | 09/26/1984SE |
| K842585 | Theophylline Kit Fluorescence Polariza-LER · Traditional | 09/26/1984SE |
| K811442 | Kwik-Lac Beta-Lactamase Kits · Traditional | 06/18/1981SE |
| K811412 | Neisseria-KwikJSX · Traditional | 06/16/1981SE |