KRX — Calibrator For Cell Indices Class II
FDA Device Classification
Classification Details
- Product Code
- KRX
- Device Class
- Class II
- Regulation Number
- 864.8150
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K160585 | streck | XN CAL | December 22, 2016 |
| K141955 | streck | XN CAL PF | December 5, 2014 |
| K141962 | streck | XN CAL | December 5, 2014 |
| K120747 | streck | XN CAL PF | October 22, 2012 |
| K120745 | streck | XN CAL | October 19, 2012 |
| K111204 | streck | CELL-DYN 22 PLUS CALIBRATOR | December 22, 2011 |
| K083200 | streck | X-CAL | February 3, 2009 |
| K020469 | streck laboratories | CAL-CHEX CD PLUS | April 4, 2002 |
| K003991 | r and d systems | CD-CAL PLUS CALIBRATOR | January 16, 2001 |
| K993375 | clinical diagnostic solutions | CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER | December 20, 1999 |
| K955925 | r and d systems | CBC-CAL PLUS HEMATOLOGY CALIBRATOR | February 29, 1996 |
| K912357 | r and d systems | 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE | July 9, 1991 |
| K862858 | r and d systems | CBC-CAL (TM) PLUS/MULTIPLE | August 21, 1986 |
| K831140 | american dade | DADE HEMATOLOGY CALIBRATOR | June 8, 1983 |
| K811741 | streck laboratories | CELL-CHEX RBC | September 24, 1981 |
| K811063 | diagnostic technology | LASER-CAL | July 1, 1981 |