FDA Product Code
FDA Product Code KSA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8185
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K943268 | SCS-1000 (SYSMEX CALIBRATOR SYSTEM) | Streck Laboratories, Inc. | 1994-12-15 | Traditional | PDF ↗ |
| K897060 | CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE | R&D Systems, Inc. | 1990-01-02 | Traditional | PDF ↗ |
| K881161 | TECH-CAL(TM)/MULTIPLE | R&D Systems, Inc. | 1988-05-02 | Traditional | PDF ↗ |
| K864664 | H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS | Technicon Instruments Corp. | 1987-02-06 | Traditional | PDF ↗ |
| K854823 | CBC-CAL/MULTIPLE | R&D Systems, Inc. | 1986-02-13 | Traditional | PDF ↗ |
| K844708 | TRI-COUNT CALIBRATOR | Hematology Marketing Assoc. | 1985-03-05 | Traditional | PDF ↗ |
| K813530 | HEMOTOLOGY CALIBRATOR | American Dade | 1982-02-22 | Traditional | PDF ↗ |
| K813375 | HEMATOLOGY CALIBRATOR S-CAL | Coulter Electronics, Inc. | 1982-02-04 | Traditional | PDF ↗ |
Product code KSA · Class II · Hematology. Data: openFDA.