Calibrator For Cell Indices
Hematology · 21 CFR 864.8150
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
32 firms currently registered for this product code
Streck Llc
La Vista, NE, US
Sysmex Corporation Techno Park
KOBE Hyogo, JP
Sysmex America, Inc.
Lincolnshire, IL, US
Abbott Laboratories
Lake Forest, IL, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
R & D Systems, Inc.
MINNEAPOLIS, MN, US
Sts Corporation
Duluth, GA, US
Mindray Ds Usa, Inc.
Mahwah, NJ, US
Beckman Coulter, Inc.
Miami, FL, US
Horiba Abx Sas
MONTPELLIER Herault, FR
Abbott Laboratories
Irving, TX, US
Jas Diagnostics/drew Scientific
Plantation, FL, US
Dirui Industrial Co., Ltd.
CHANGCHUN Jilin, CN
B&e Bio-technology Co., Ltd.
Yantai Shandong, CN
510(k) clearances
16 clearances for this product code
- StreckDec 22, 2016
K160585 · XN CAL
- StreckDec 5, 2014
K141962 · XN CAL
- StreckDec 5, 2014
K141955 · XN CAL PF
- StreckOct 22, 2012
K120747 · XN CAL PF
- StreckOct 19, 2012
K120745 · XN CAL
- StreckDec 22, 2011
K111204 · CELL-DYN 22 PLUS CALIBRATOR
- StreckFeb 3, 2009
K083200 · X-CAL
- Streck Laboratories, Inc.Apr 4, 2002
K020469 · CAL-CHEX CD PLUS