KRX · Class II · 21 CFR 864.8150

FDA Product Code KRX: Calibrator For Cell Indices

Leading manufacturers include Streck, R&D Systems, Inc. and Streck Laboratories, Inc..

16
Total
16
Cleared
117d
Avg days
1981
Since

FDA 510(k) Cleared Calibrator For Cell Indices Devices (Product Code KRX)

16 devices
1–16 of 16
Cleared Dec 22, 2016
XN CAL
K160585
Streck
Hematology · 296d
Cleared Dec 05, 2014
XN CAL PF
K141955
Streck
Hematology · 140d
Cleared Dec 05, 2014
XN CAL
K141962
Streck
Hematology · 140d
Cleared Oct 22, 2012
XN CAL PF
K120747
Streck
Hematology · 224d
Cleared Oct 19, 2012
XN CAL
K120745
Streck
Hematology · 221d
Cleared Dec 22, 2011
CELL-DYN 22 PLUS CALIBRATOR
K111204
Streck
Hematology · 237d
Cleared Feb 03, 2009
X-CAL
K083200
Streck
Hematology · 96d
Cleared Apr 04, 2002
CAL-CHEX CD PLUS
K020469
Streck Laboratories, Inc.
Hematology · 51d
Cleared Jan 16, 2001
CD-CAL PLUS CALIBRATOR
K003991
R&D Systems, Inc.
Hematology · 21d
Cleared Dec 20, 1999
CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER
K993375
Clinical Diagnostic Solutions, Inc.
Hematology · 74d
Cleared Feb 29, 1996
CBC-CAL PLUS HEMATOLOGY CALIBRATOR
K955925
R&D Systems, Inc.
Hematology · 69d
Cleared Jul 09, 1991
3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE
K912357
R&D Systems, Inc.
Hematology · 42d
Cleared Aug 21, 1986
CBC-CAL (TM) PLUS/MULTIPLE
K862858
R&D Systems, Inc.
Hematology · 23d
Cleared Jun 08, 1983
DADE HEMATOLOGY CALIBRATOR
K831140
American Dade
Hematology · 62d
Cleared Sep 24, 1981
CELL-CHEX RBC
K811741
Streck Laboratories, Inc.
Hematology · 97d
Cleared Jul 01, 1981
LASER-CAL
K811063
Diagnostic Technology, Inc.
Hematology · 75d

About Product Code KRX - Regulatory Context