KRY · Calibrator For Platelet Counting
Hematology · 21 CFR 864.8175 · Class 2
Overview
| Product Code | KRY |
|---|---|
| Device Name | Calibrator For Platelet Counting |
| Regulation | 21 CFR 864.8175 |
| Device Class | Class 2 |
| Review Panel | Hematology |
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.
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 |
|---|---|---|---|---|
| K862122 | S-CAL HEMATOLOGY CALIBRATOR | Coulter Electronics, Inc. | May 20, 1987 | SESE |
| K852016 | LASER PLATELETCAL/MULTIPLE | R&D Systems, Inc. | Jul 9, 1985 | SESE |
| K843910 | COULTER MEAN PLATELET VOLUME CALIBRATOR | Coulter Electronics, Inc. | Jan 7, 1985 | SESE |
| K840794 | S-CAL HEMATOLOGY CALIBRATOR | Coulter Electronics, Inc. | Apr 4, 1984 | SESE |
| K821851 | CONTROL DIAGNOSTICS PLATELET CONTROL | Immunogenetics | Sep 2, 1982 | SESE |
| K781601 | TEKNI-CAL | Streck Laboratories, Inc. | Oct 10, 1978 | SESE |
| K781133 | PC-CALIBRATOR | Streck Laboratories, Inc. | Aug 14, 1978 | SESE |
| K770143 | TQC CALIBRATION REFERENCE FOR PLATELETS | Technicon Instruments Corp. | Jan 30, 1978 | SESE |
Top Applicants
- Coulter Electronics, Inc. — 3 clearances
- Streck Laboratories, Inc. — 2 clearances
- Immunogenetics — 1 clearance
- R&D Systems, Inc. — 1 clearance
- Technicon Instruments Corp. — 1 clearance
