Reagent & Control, Partial Thromboplastin Time
FDA product code GIT · Class II (moderate risk) · 21 CFR 864.7925 · Hematology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K890051 | Biotrack Aptt ControlsGIT · Traditional | Biotrack, Inc. | 02/23/1989SE |
| K881999 | Platelin(R) Excel LGIT · Traditional | Organon Teknika Corp. | 08/17/1988SE |
| K880711 | CLP 0.02 M Calcium Chloride Solution.GIT · Traditional | Creative Laboratory Products, Inc. | 03/18/1988SE |
| K820450 | ThromboscreenGIT · Traditional | Pacific Hemostasis | 03/26/1982SE |