Red-Cell Indices, Calculated
FDA product code JPJ · Class II (moderate risk) · 21 CFR 864.5300 · Hematology
3510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K904675 | QBC System MCHCJPJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/02/1990SE |
| K780946 | Royco Model 970 Hematology Data AnalyzerJPJ · Traditional | Hycel, Inc. | 07/27/1978SE |
| K761304 | JTB 700 Hematology AnalyzerJPJ · Traditional | J.T. Baker Chemical Co. | 02/01/1977SE |