Test, Leukocyte Typing
FDA product code LGO · Class I (low risk) · 21 CFR 864.7675 · Hematology
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K894947 | Platelia Toxo Igg KitLGO · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 03/23/1990SE |
| K874544 | Snap(R) Campylobacter Culture Ident Diagnostic KitLGO · Traditional | Molecular Biosystems, Inc. | 08/12/1988SE |
| K791118 | Hla Control SeraLGO · Traditional | Calbiochem-Behring Corp. | 08/03/1979SE |
| K761009 | Lymphocyte Typing, Positive ControlLGO · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 04/06/1977SE |
| K761008 | Lymphocyte Typing, Negative ControlLGO · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 04/06/1977SE |