FDA 510(k) Applications Submitted by Deborah 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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