FDA Product Code
FDA Product Code KRY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8175
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K862122 | S-CAL HEMATOLOGY CALIBRATOR | Coulter Electronics, Inc. | 1987-05-20 | Traditional | PDF ↗ |
| K852016 | LASER PLATELETCAL/MULTIPLE | R&D Systems, Inc. | 1985-07-09 | Traditional | PDF ↗ |
| K843910 | COULTER MEAN PLATELET VOLUME CALIBRATOR | Coulter Electronics, Inc. | 1985-01-07 | Traditional | PDF ↗ |
| K840794 | S-CAL HEMATOLOGY CALIBRATOR | Coulter Electronics, Inc. | 1984-04-04 | Traditional | PDF ↗ |
| K821851 | CONTROL DIAGNOSTICS PLATELET CONTROL | Immunogenetics | 1982-09-02 | Traditional | PDF ↗ |
| K781601 | TEKNI-CAL | Streck Laboratories, Inc. | 1978-10-10 | Traditional | PDF ↗ |
| K781133 | PC-CALIBRATOR | Streck Laboratories, Inc. | 1978-08-14 | Traditional | PDF ↗ |
| K770143 | TQC CALIBRATION REFERENCE FOR PLATELETS | Technicon Instruments Corp. | 1978-01-30 | Traditional | PDF ↗ |
Product code KRY · Class II · Hematology. Data: openFDA.