FDA 510(k) Applications Submitted by Kyu Kim
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K231514 |
05/25/2023 |
Azure |
Daeshin Enterprise Co., Ltd. |
| 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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