Turbidimetric Method, Lipoproteins
FDA product code JHN · Class I (low risk) · 21 CFR 862.1475 · Clinical Chemistry
7510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950383 | Apolipoprotein A-I Immunoturbidimetric KitJHN · Traditional | Randox Laboratories, Ltd. | 09/15/1995SE |
| K950382 | Apolipoprotein B Immunoturbidiemetric KitJHN · Traditional | Randox Laboratories, Ltd. | 09/15/1995SE |
| K952615 | Wako Autokit Apo A1JHN · Traditional | Wako Chemicals USA, Inc. | 09/08/1995SE |
| K952425 | Olympus Apolipoprotein A1 Immunoturbidimetric ReagentJHN · Traditional | Olympus America, Inc. | 07/05/1995SE |
| K952466 | Olympus Apolipoprotein B Immunoturbidimetric ReagentJHN · Traditional | Olympus America, Inc. | 06/05/1995SE |
| K932606 | Apolipoprotien A-1 (Apo A-1)JHN · Traditional | Sigma Diagnostics, Inc. | 06/02/1994SE |
| K932603 | Apolipoprotien B (Apo B)JHN · Traditional | Sigma Diagnostics, Inc. | 06/02/1994SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1815-2025 Class III | Apo B Reagent, REF: OSR6143The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was… | Beckman Coulter Ireland, Inc. | 04/23/2025Open, Classified |