Labsystems, Inc.
Medical device manufacturer in Highlands Ranch, CO.
17510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K923365 | Tilt/Reduced Shear Semi-Recline Seating SystemITI · Traditional | 03/24/1993SE |
| K896474 | Resubmitted Fecatwin Sensitive - Feca-EiaKHE · Traditional | 01/25/1990SE |
| K890154 | Modified Labysystems' Toxoplasma Gondii Igg EiaLGD · Traditional | 02/07/1989SE |
| K890091 | Modified Labsystems' Rubella Igg Eia Test KitLFX · Traditional | 02/03/1989SE |
| K881243 | Rubella Igg - Eia Test Kit Number 61 07 201LFX · Traditional | 04/04/1988SE |
| K873780 | Modification Rubella Igm Eia Test KitLFX · Traditional | 10/15/1987SE |
| K873583 | Auto-EiaJJQ · Traditional | 09/22/1987SE |
| K872252 | Modified Toxoplasma Gondii Igg Eia Test KitLGD · Traditional | 07/01/1987SE |
| K862705 | Cytomegalovirus Igg Eia Test KitGQI · Traditional | 10/01/1986SE |
| K862431 | Rubella Igm Eia Test KitLFX · Traditional | 08/08/1986SE |
| K862216 | Toxoplasma Gondii Igg Eia Test Kit (Amendment)LGD · Traditional | 06/30/1986SE |
| K853696 | Rubella Igg Eia Test KitLFX · Traditional | 06/17/1986SE |
| K843189 | Cytomegalovirus Igg Eia Test KitGQI · Traditional | 01/08/1986SE |
| K842797 | Toxoplasma Gondii Igm Eia Test KitLGD · Traditional | 10/17/1984SE |
| K842773 | Labsystems FP-901 Chemistry AnalyzerJJE · Traditional | 09/04/1984SE |
| K833829 | Toxoplasma Gond II Igg Dia Test KitLGD · Traditional | 04/24/1984SE |
| K841214 | Labsystems UniskanJJQ · Traditional | 04/13/1984SE |