Heavy Metals Control Materials
FDA product code DIE · Class I (low risk) · 21 CFR 862.3280 · Clinical Toxicology
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020610 | Lyphochek Whole Blood Metals Control Model # 527, 528, 529DIE · Traditional | Bio-Rad | 04/22/2002SE |
| K990928 | Lyphocheck Urine Metals Control, Item NO.400, 405DIE · Traditional | Bio-Rad | 04/16/1999SE |
| K891691 | Lyphochek Urine Metals Control, Levels I and IIDIE · Traditional | Bio-Rad | 12/19/1989SE |
| K890721 | Shape-Actio Metal Toxicology ControlDIE · Traditional | Actio, Inc. | 04/10/1989SE |
| K863915 | Shape-Actio Metal Toxicology ControlDIE · Traditional | Shape Products Co. | 11/24/1986SE |