Hand-Tally, Differential
FDA product code GKM · Class I (low risk) · 21 CFR 864.6160 · Hematology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874188 | Coulter Immunoprep Leukocyte/Q-Prep Immuno WRK StaGKM · Traditional | Coulter Electronics, Inc. | 01/19/1988SE |
| K854685 | DIGITAL-9 Key Leucocyte CounterGKM · Traditional | Future Impex Corp. | 04/04/1986SE |
| K841026 | Manual Blood Cell Counting DeviceGKM · Traditional | Instrumentation Laboratory CO | 04/04/1984SE |
| K771580 | Tektally IIGKM · Traditional | Scientific Products | 09/02/1977SE |