FDA 510(k) Applications Submitted by Kyung Hwa Kim

FDA 510(k) Number Submission Date Device Name Applicant
K142275 08/15/2014 Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens NEO VISION CO., LTD.
K201038 04/20/2020 Luce Ceramic Bracket Luce Castle Co., Ltd.
K100341 02/05/2010 SPERMCHECK FERTILITY PRINCETON BIOMEDITECH CORP.
K130650 03/11/2013 STATUS DS OXY PRINCETON BIOMEDITECH CORP.
K050955 04/15/2005 LIFESIGN DXPRESS, MODEL LSR2000 PRINCETON BIOMEDITECH CORP.
K182157 08/09/2018 BioSign Flu A+B Princeton BioMeditech Corp.
K062565 08/31/2006 STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE PRINCETON BIOMEDITECH CORP.
K062575 08/31/2006 MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP PRINCETON BIOMEDITECH CORP.
K082661 09/12/2008 BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A PRINCETON BIOMEDITECH CORP.
K073039 10/29/2007 SPERMCHECK VASECTOMY PRINCETON BIOMEDITECH CORP.
K133474 11/12/2013 BIOSIGN FLU A + B, STATUS FLU A & B PRINCETON BIOMEDITECH CORP.
K083746 12/17/2008 BIOSIGN FLU A+B PRINCETON BIOMEDITECH CORP.
K132465 08/07/2013 BIOSIGN FLU A + B, STATUS FLU A & B PRINCETON BIOMEDITECH CORP.


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