KRY
8 FDA 510(k) clearances · Product code
71 daysmedian time to decision
371 days90th percentile
8clearances measured
FDA profile
- Official device name
- Calibrator For Platelet Counting
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8175
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 2011: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| S-CAL HEMATOLOGY CALIBRATOR (K862122) | Coulter Electronics, Inc. | 1987-05-20 |
| LASER PLATELETCAL/MULTIPLE (K852016) | R&D Systems, Inc. | 1985-07-09 |
| COULTER MEAN PLATELET VOLUME CALIBRATOR (K843910) | Coulter Electronics, Inc. | 1985-01-07 |
| S-CAL HEMATOLOGY CALIBRATOR (K840794) | Coulter Electronics, Inc. | 1984-04-04 |
| CONTROL DIAGNOSTICS PLATELET CONTROL (K821851) | Immunogenetics | 1982-09-02 |
| TEKNI-CAL (K781601) | Streck Laboratories, Inc. | 1978-10-10 |
| PC-CALIBRATOR (K781133) | Streck Laboratories, Inc. | 1978-08-14 |
| TQC CALIBRATION REFERENCE FOR PLATELETS (K770143) | Technicon Instruments Corp. | 1978-01-30 |
Track KRY automatically
Every clearance here is in the API, with alerts when new ones post.