Primus Corp.
Medical device manufacturer in Kansas City, MO.
14510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K062658 | Primus A1CARE AssayLCP · Traditional | 11/26/2007SE |
| K013787 | Nycocard CRPDCK · Traditional | 05/14/2002SE |
| K014084 | Nycocard CRP ControlDCK · Traditional | 01/07/2002SE |
| K993131 | Nycocard HBA1C Glycosylated Hemoglobin AssayLCP · Traditional | 05/22/2000SE |
| K994045 | Primus Liquid Calibrator for GHB/A1C Level 1 and Level 2LCP · Special | 12/21/1999SE |
| K992921 | Primus Liquid Control for Ghb/Alc Level I and Level IILCP · Traditional | 11/12/1999SE |
| K955283 | Primus Variant System PVS99GKA · Traditional | 03/01/1996SE |
| K942009 | Primus Rapid Gel 100 Glycated Hemoglobin AssayLCP · Traditional | 09/14/1994SE |
| K940008 | Glycated Protein CalibratorsJIS · Traditional | 05/09/1994SE |
| K940142 | Glycated Protein ControlsJJX · Traditional | 04/26/1994SE |
| K936204 | Glycated Hemoglobin CalibratorsLCP · Traditional | 03/22/1994SE |
| K940143 | Glycated Hemoglobin ControlsLCP · Traditional | 03/15/1994SE |
| K896582 | Diabetes Care(Tm) Test Package for the CLC 330(TM)LCP · Traditional | 06/28/1990SE |
| K891235 | Primus Model CLC 330LCP · Traditional | 06/16/1989SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0321-2021 Class II | Ultra2 Resolution Variants System for Abnormal Hemoglobin QuantitationThe product did not receive pre-market approval or clearance. | 10/09/2020Terminated |