Calibrator For Red-Cell And White-Cell Counting
FDA product code KSA · Class II (moderate risk) · 21 CFR 864.8185 · Hematology
8510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K943268 | SCS-1000 (Sysmex Calibrator System)KSA · Traditional | Streck Laboratories, Inc. | 12/15/1994SE |
| K897060 | Cbc-Cal(Tm) Plus Hematology Calibrator/MultipleKSA · Traditional | R&D Systems, Inc. | 01/02/1990SE |
| K881161 | Tech-Cal(Tm)/MultipleKSA · Traditional | R&D Systems, Inc. | 05/02/1988SE |
| K864664 | H-1 Setpoint Platelet and Rbc/Wbc CalibratorsKSA · Traditional | Technicon Instruments Corp. | 02/06/1987SE |
| K854823 | Cbc-Cal/MultipleKSA · Traditional | R&D Systems, Inc. | 02/13/1986SE |
| K844708 | Tri-Count CalibratorKSA · Traditional | Hematology Marketing Assoc. | 03/05/1985SE |
| K813530 | Hemotology CalibratorKSA · Traditional | American Dade | 02/22/1982SE |
| K813375 | Hematology Calibrator S-CalKSA · Traditional | Coulter Electronics, Inc. | 02/04/1982SE |