Product code KRX— Hematology
XN CAL
- Classification name
- Calibrator For Cell Indices
- Device class
- Class 2
- Regulation
- 21 CFR 864.8150
- Advisory panel
- Hematology
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code KRX
FDA has cleared devices under product code KRX between 1981 and 2016, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2016
- 2014
- 2012
- 2011
- 2009
- 2002
- 2001
- 1999
- 1996
- 1991
- 1986
- 1983
- 1981
Top applicants under product code KRX
Recent clearances under product code KRX
- K160585 — XN CAL
- K141955 — XN CAL PF
- K141962 — XN CAL
- K120747 — XN CAL PF
- K120745 — XN CAL
- K111204 — CELL-DYN 22 PLUS CALIBRATOR
- K083200 — X-CAL
- K020469 — CAL-CHEX CD PLUS
- K003991 — CD-CAL PLUS CALIBRATOR
- K993375 — CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER
- K955925 — CBC-CAL PLUS HEMATOLOGY CALIBRATOR
- K912357 — 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE
- K862858 — CBC-CAL (TM) PLUS/MULTIPLE
- K831140 — DADE HEMATOLOGY CALIBRATOR
- K811741 — CELL-CHEX RBC
- K811063 — LASER-CAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.