KSA · Calibrator For Red-Cell And White-Cell Counting
Hematology · 21 CFR 864.8185 · Class 2
Overview
| Product Code | KSA |
|---|---|
| Device Name | Calibrator For Red-Cell And White-Cell Counting |
| Regulation | 21 CFR 864.8185 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A calibrator for red cell and white cell counting is a device that resembles red or white blood cells and that is used to set instruments intended to count red cells, white cells, or both. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K943268 | SCS-1000 (SYSMEX CALIBRATOR SYSTEM) | Streck Laboratories, Inc. | Dec 15, 1994 | SESE |
| K897060 | CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE | R&D Systems, Inc. | Jan 2, 1990 | SESE |
| K881161 | TECH-CAL(TM)/MULTIPLE | R&D Systems, Inc. | May 2, 1988 | SESE |
| K864664 | H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS | Technicon Instruments Corp. | Feb 6, 1987 | SESE |
| K854823 | CBC-CAL/MULTIPLE | R&D Systems, Inc. | Feb 13, 1986 | SESE |
| K844708 | TRI-COUNT CALIBRATOR | Hematology Marketing Assoc. | Mar 5, 1985 | SESE |
| K813530 | HEMOTOLOGY CALIBRATOR | American Dade | Feb 22, 1982 | SESE |
| K813375 | HEMATOLOGY CALIBRATOR S-CAL | Coulter Electronics, Inc. | Feb 4, 1982 | SESE |
Top Applicants
- R&D Systems, Inc. — 3 clearances
- American Dade — 1 clearance
- Coulter Electronics, Inc. — 1 clearance
- Hematology Marketing Assoc. — 1 clearance
- Streck Laboratories, Inc. — 1 clearance
