Control, Platelet
FDA product code GJP · Class II (moderate risk) · 21 CFR 864.8625 · Hematology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K880608 | Msi-PcGJP · Traditional | Medical Specialties, Inc. | 03/21/1988SE |
| K823930 | Hematology Quality Control MixtureGJP · Traditional | Fisher Scientific Co., LLC | 02/01/1983SE |
| K771588 | Platelet Controls Normal & AbnormalGJP · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 08/25/1977SE |
| K770655 | Latelet Determibation Kit, Ul 800GJP · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/24/1977SE |