KSA — Calibrator For Red-Cell And White-Cell Counting Class II
FDA product code KSA covers "Calibrator For Red-Cell And White-Cell Counting", a Class II medical device regulated under 21 CFR 864.8185. Submissions are reviewed by the Hematology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KSA
- Device Class
- Class II
- Regulation Number
- 864.8185
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K943268 | streck laboratories | SCS-1000 (SYSMEX CALIBRATOR SYSTEM) | December 15, 1994 |
| K897060 | r and d systems | CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE | January 2, 1990 |
| K881161 | r and d systems | TECH-CAL(TM)/MULTIPLE | May 2, 1988 |
| K864664 | technicon instruments | H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS | February 6, 1987 |
| K854823 | r and d systems | CBC-CAL/MULTIPLE | February 13, 1986 |
| K844708 | hematology marketing assoc | TRI-COUNT CALIBRATOR | March 5, 1985 |
| K813530 | american dade | HEMOTOLOGY CALIBRATOR | February 22, 1982 |
| K813375 | coulter electronics | HEMATOLOGY CALIBRATOR S-CAL | February 4, 1982 |