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FDA 510(k) Applications Submitted by Deborah S. Kipp
FDA 510(k) Number
Submission Date
Device Name
Applicant
K170091
01/10/2017
UA-Cellular Complete
Streck
DEN200001
01/10/2020
Cell-Free DNA BCT
Streck, Inc.
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
K010500
02/21/2001
AUTOMATED WORKCELL CONTROL SOFTWARE
LAB-INTERLINK, INC.
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
K212576
08/16/2021
MDx-Chex for BCID2
Streck, Inc
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