FDA 510(k) Applications Submitted by Su Hyeon So
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K203417 |
11/19/2020 |
DVT-4000S |
Daesung Maref CO., LTD. |
| K122377 |
07/23/2012 |
POWDER FREE VINYL EXAMINATION GLOVES |
SHU TONG XINGHUA CO., LTD. |
| K231437 |
05/17/2023 |
LF900 |
Daesung Maref Co., Ltd |
| K203016 |
10/01/2020 |
DVT-2600 |
Daesung Maref Co., LTD |
| K203353 |
11/13/2020 |
DVT-PRO |
Daesung Maref Co., LTD |
| K203498 |
11/27/2020 |
LX9max |
Daesung Maref CO., LTD. |
| K122176 |
07/23/2012 |
POWDERED VINYL EXAMINATION GLOVES |
SHU TONG XINGHUA CO., LTD. |
| K210904 |
03/26/2021 |
Metapaste Plus |
Meta Biomed Co., Ltd. |
| K181689 |
06/26/2018 |
Nexcomp |
Meta Biomed Co., Ltd. |
| K232299 |
08/01/2023 |
CeraPutty |
Meta Biomed Co., Ltd. |
| K230010 |
01/03/2023 |
ADSEAL Plus |
Meta Biomed Co., LTD. |
| K230009 |
01/03/2023 |
EZ Bond Universal |
Meta Biomed Co., LTD. |
| K190510 |
03/01/2019 |
GuttaSil |
Meta Biomed Co., Ltd. |
| K190503 |
03/01/2019 |
CeraSeal |
Meta Biomed Co., Ltd. |
| K190724 |
03/20/2019 |
MD-Temp Plus |
Meta Biomed Co., Ltd |
| K180802 |
03/28/2018 |
Meta P&Bond |
META BIOMED, CO., LTD. |
| K171449 |
05/17/2017 |
Metacem |
Meta Biomed Co., Ltd |
| K191991 |
07/25/2019 |
Ezfil |
Meta Biomed Co., Ltd. |
| K202617 |
09/09/2020 |
Metapex Plus |
Meta Biomed Co., Ltd. |
| K152879 |
09/30/2015 |
Sure-Fine Insulin Syringes |
SHINA MED CORPORATION |
| K152877 |
09/30/2015 |
SureFine Pen Needle |
SHINA MED CORPORATION |
| K101968 |
07/12/2010 |
SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A |
ST. JUDE MEDICAL |
| K110788 |
03/22/2011 |
INNOVA WHEELCHAIR |
COLUMBIA MEDICAL MANUFACTURING, LLC |
| K961886 |
05/15/1996 |
DRAGER GEMINA WALL-MOUNTED WORKPLACE |
ALM SURGICAL EQUIPMENT, INC. |
| K962319 |
06/17/1996 |
NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES |
NEOPROBE CORP. |
| K971167 |
03/31/1997 |
NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES |
NEOPROBE CORP. |
| K190150 |
01/30/2019 |
Sage 2-in-1 Personal Lubricant and Moisturizer |
Fairhaven Health, LLC |
| K162319 |
08/19/2016 |
BabyDance Fertility Lubricant |
Fairhaven Health, LLC |
| K130162 |
01/23/2013 |
LIQUID ASSAYED MULTIQUAL PREMIUM |
Bio-Rad Laboratories |
| K100727 |
03/15/2010 |
LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK |
BIO-RAD, DIAGNOSTICS GRP. |
| K130761 |
03/20/2013 |
LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK |
Bio-Rad Laboratories |
| K140764 |
03/27/2014 |
LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK |
Bio-Rad Laboratories |
| K130963 |
04/08/2013 |
LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK |
BIO-RAD LABORATORIES, INC. |
| K140916 |
04/10/2014 |
LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK |
Bio-Rad Laboratories |
| K141073 |
04/25/2014 |
LIQUICHEK TUMOR MARKER CONTROL |
Bio-Rad Laboratories |
| K121794 |
06/19/2012 |
LIQUICHEK URINE CHEMISTRY CONTROL |
BIO-RAD, DIAGNOSTICS GRP. |
| K132227 |
07/17/2013 |
LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY |
Bio-Rad Laboratories |
| K122838 |
09/17/2012 |
LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK |
Bio-Rad Laboratories |
| K072835 |
10/03/2007 |
LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK |
BIO-RAD, DIAGNOSTICS GRP. |
| K123198 |
10/11/2012 |
LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA |
Bio-Rad Laboratories |
| K123663 |
11/28/2012 |
LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK |
Bio-Rad Laboratories |
| K123798 |
12/10/2012 |
LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK |
Bio-Rad Laboratories |
| K123775 |
12/10/2012 |
LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK |
Bio-Rad Laboratories |
| K133960 |
12/24/2013 |
LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL |
Bio-Rad Laboratories |
| K134013 |
12/30/2013 |
LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO |
Bio-Rad Laboratories |
| K122558 |
08/22/2012 |
ULTRASAFE PASSIVE NEEDLE GUARD |
SAFETY SYRINGES, INC. |
| K123743 |
12/06/2012 |
ULTRASAFE PLUS PASSIVE NEEDLE GUARD |
SAFETY SYRINGES, INC. |
| K050537 |
03/02/2005 |
LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS |
BIO-RAD |
| K091303 |
05/04/2009 |
LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV |
Bio-Rad Laboratories |
| K052053 |
07/29/2005 |
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK |
BIO-RAD |
| K042865 |
10/18/2004 |
LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) |
BIO-RAD |
| K043108 |
11/09/2004 |
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL |
BIO-RAD LABORATORIES, INC. |
| K043584 |
12/28/2004 |
LIQUICHEK BNP CONTROL |
BIO-RAD LABORATORIES, INC. |
| K121143 |
04/16/2012 |
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) |
Bio-Rad Laboratories |
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