KRY — Calibrator For Platelet Counting Class II
FDA product code KRY covers "Calibrator For Platelet Counting", a Class II medical device regulated under 21 CFR 864.8175. Submissions are reviewed by the Hematology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KRY
- Device Class
- Class II
- Regulation Number
- 864.8175
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K862122 | coulter electronics | S-CAL HEMATOLOGY CALIBRATOR | May 20, 1987 |
| K852016 | r and d systems | LASER PLATELETCAL/MULTIPLE | July 9, 1985 |
| K843910 | coulter electronics | COULTER MEAN PLATELET VOLUME CALIBRATOR | January 7, 1985 |
| K840794 | coulter electronics | S-CAL HEMATOLOGY CALIBRATOR | April 4, 1984 |
| K821851 | immunogenetics | CONTROL DIAGNOSTICS PLATELET CONTROL | September 2, 1982 |
| K781601 | streck laboratories | TEKNI-CAL | October 10, 1978 |
| K781133 | streck laboratories | PC-CALIBRATOR | August 14, 1978 |
| K770143 | technicon instruments | TQC CALIBRATION REFERENCE FOR PLATELETS | January 30, 1978 |