FDA 510(k) Applications Submitted by STRECK

FDA 510(k) Number Submission Date Device Name Applicant
K080552 02/28/2008 CYTO-CHEX BCT Streck
K051633 06/20/2005 CD-CHEX PLUS BC Streck
K170091 01/10/2017 UA-Cellular Complete Streck
K160585 03/01/2016 XN CAL Streck
K160586 03/01/2016 XN-L CHECK STRECK
K160588 03/01/2016 XN CHECK BF STRECK
K160590 03/01/2016 XN CHECK STRECK
K110718 03/15/2011 CELL-CHEX WITH CPPD CRYSTALS Streck
K111204 04/29/2011 CELL-DYN 22 PLUS CALIBRATOR Streck
K111211 04/29/2011 CELL-DYN 22 PLUS CONTROL Streck
K131444 05/20/2013 UA-CELLULAR COMPLETE Streck
K141955 07/18/2014 XN CAL PF Streck
K141957 07/18/2014 XN CHECK BF Streck
K141962 07/18/2014 XN CAL Streck
K141964 07/18/2014 XN CHECK Streck
K120742 03/12/2012 XN CHECK Streck
K120744 03/12/2012 XN CHECK BF Streck
K120745 03/12/2012 XN CAL Streck
K120747 03/12/2012 XN CAL PF Streck
K080016 01/03/2008 NRBC-CHEX FOR ADVIA Streck
K083200 10/30/2008 X-CAL Streck
K060083 01/11/2006 NRBC-CHEX FOR LH Streck
K090137 01/21/2009 STAK-CHEX PLUS RETICS Streck
K070199 01/22/2007 RETIC-CHEX LINEARITY FOR BC Streck
K090201 01/27/2009 UA-CELLULAR FOR IQ Streck
K101335 05/12/2010 CELL-CHEX Streck
K063218 10/24/2006 E-CHECK (XE) Streck
K053362 12/02/2005 CELL-CHEX AUTO Streck
K083926 12/31/2008 CD4 COUNT Streck
K051706 06/27/2005 IQ BODY FLUIDS CONTROL Streck


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