Abbott Mfg., Inc.
Medical device manufacturer in Irving, TX.
14510(k) clearances
0PMA approvals
0recalls
Device types
- FRN Pump, Infusion 2
- CFT Radioimmunoassay, Prolactin (Lactogen) 2
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 1
- LCD Enzyme Immunoassay, Gentamicin 1
- JJE Analyzer, Chemistry (Photometric… 1
- FPK Tubing, Fluid Delivery 1
- LZH Pump, Infusion, Enteral 1
- CGN Acid, Folic, Radioimmunoassay 1
- FPA Set, Administration, Intravascular 1
- KHS Enzymatic, Carbon-Dioxide 1
- CJY Azo Dye, Calcium 1
- CJW Bromcresol Purple Dye-Binding, Albumin 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K981457 | AlbpCJW · Traditional | 05/27/1998SE |
| K981232 | CaCJY · Traditional | 05/18/1998SE |
| K981231 | CO2KHS · Traditional | 05/12/1998SE |
| K965230 | Abbott Lifecare Standard Tubing Infusion PumpFRN · Traditional | 07/03/1997SE |
| K971293 | Lifeshield Primary I.V. Set with Backcheck ValveFPA · Traditional | 06/27/1997SE |
| K953656 | Abbott Imx Prolactin(Modification)CFT · Traditional | 10/03/1995SE |
| K953657 | Abbott Axsym Prolactin(Modification)CFT · Traditional | 09/25/1995SE |
| K944669 | Flexiflo Quantum Enteral PumpFRN · Traditional | 07/24/1995SE |
| K943691 | Imx FolateCGN · Traditional | 03/23/1995SE |
| K943733 | Flexiflo Six Enteral Nutrition PumpLZH · Traditional | 12/12/1994ST |
| K941214 | Lifeshield Extension SetFPK · Traditional | 10/03/1994SE |
| K940289 | Abbott Prism AnalyzerJJE · Traditional | 07/18/1994SE |
| K935376 | Axsym GentamicinLCD · Traditional | 06/21/1994SE |
| K902753 | Imx Ultrasentitive HTSHJLW · Traditional | 07/10/1990SE |