KSA
8 FDA 510(k) clearances · Product code
70 daysmedian time to decision
161 days90th percentile
8clearances measured
FDA profile
- Official device name
- Calibrator For Red-Cell And White-Cell Counting
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8185
- Medical specialty
- Hematology
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| Record | Firm | Date | Builder |
|---|---|---|---|
| SCS-1000 (SYSMEX CALIBRATOR SYSTEM) (K943268) | Streck Laboratories, Inc. | 1994-12-15 | + Add |
| CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE (K897060) | R&D Systems, Inc. | 1990-01-02 | + Add |
| TECH-CAL(TM)/MULTIPLE (K881161) | R&D Systems, Inc. | 1988-05-02 | + Add |
| H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS (K864664) | Technicon Instruments Corp. | 1987-02-06 | + Add |
| CBC-CAL/MULTIPLE (K854823) | R&D Systems, Inc. | 1986-02-13 | + Add |
| TRI-COUNT CALIBRATOR (K844708) | Hematology Marketing Assoc. | 1985-03-05 | + Add |
| HEMOTOLOGY CALIBRATOR (K813530) | American Dade | 1982-02-22 | + Add |
| HEMATOLOGY CALIBRATOR S-CAL (K813375) | Coulter Electronics, Inc. | 1982-02-04 | + Add |
Track KSA automatically
Every clearance here is in the API, with alerts when new ones post.