S-CAL HEMATOLOGY CALIBRATOR
Device Facts
| Record ID | K840794 |
|---|---|
| Device Name | S-CAL HEMATOLOGY CALIBRATOR |
| Applicant | Coulter Electronics, Inc. |
| Product Code | KRY · Hematology |
| Decision Date | Apr 4, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.8175 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A calibrator for platelet counting is a device that resembles platelets in plasma or whole blood and that is used to set a platelet counting instrument. It is a suspension of particles or cells whose size, shape concentration, and other characteristics have been precisely and accurately determined.
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.
