Test, Leukocyte Alkaline Phosphatase
FDA product code GHD · Class I (low risk) · 21 CFR 864.7660 · Hematology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K904022 | Nitro Blue Tetrazolium ReductionGHD · Traditional | Sigma Chemical Co. | 12/18/1990SE |
| K903995 | Naphthol As-D Chlor/A-Naphthyl Acet Esterase KitGHD · Traditional | Sigma Chemical Co. | 12/13/1990SE |
| K896092 | Alkaline Phosphatase, Leukocyte, KitGHD · Traditional | Sigma Chemical Co. | 11/09/1989SE |
| K811189 | Chemstrip LGHD · Traditional | Biodynamics Corp. | 07/27/1981SE |