Bothrops Atrox Reagent
FDA product code JCO · Class II (moderate risk) · 21 CFR 864.8100 · Hematology
7510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955115 | Venom Tiem ReagentJCO · Traditional | Medical Diagnostic Technologies, Inc. | 04/03/1996SE |
| K932787 | Batroxobin ReagentJCO · Traditional | Behring Diagnostics, Inc. | 11/29/1993SE |
| K896033 | FDP Collection TubesJCO · Traditional | Medical Diagnostic Technologies, Inc. | 10/27/1989SE |
| K852519 | Dupont Aca Fibrin Degradation Prod Clotting TubeJCO · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 08/12/1985SE |
| K843207 | Reptilase -PcJCO · Traditional | Bio/Data Corp. | 10/23/1984SE |
| K840210 | Reptilase-R HA35JCO · Traditional | Wellcome Diagnostics | 04/23/1984SE |
| K780355 | AtroxinJCO · Traditional | Sigma Chemical Co. | 04/18/1978SE |