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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
K231223
04/28/2023
MDx-Chex for BC-GN
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
K231221
04/28/2023
MDx-Chex for BC-GP
Streck
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