KRX — Calibrator For Cell Indices Class II
FDA product code KRX covers "Calibrator For Cell Indices", a Class II medical device regulated under 21 CFR 864.8150. Submissions are reviewed by the Hematology panel. At least 16 recent 510(k) clearances have been granted under this product code.
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 |
| K141962 | streck | XN CAL | December 5, 2014 |
| K141955 | streck | XN CAL PF | 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 |