FDA 510(k) Applications Submitted by Feng-Yu Lee
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140210 |
01/28/2014 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 |
BIONIME CORPORATION |
| K130213 |
01/29/2013 |
QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE |
LUMIQUICK DIAGNOSTICS, INC. |
| K120423 |
02/13/2012 |
BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 |
BIONIME CORPORATION |
| K070921 |
04/02/2007 |
BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG |
APPLIED DNA TECHNOLOGIES, INC. |
| K061005 |
04/11/2006 |
ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS |
APPLIED DNA TECHNOLOGIES, INC. |
| K071030 |
04/11/2007 |
BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC |
APPLIED DNA TECHNOLOGIES, INC. |
| K141292 |
05/19/2014 |
Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System |
BIONIME COPORATION |
| K141862 |
07/10/2014 |
HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE |
H2 Inc. |
| K132929 |
09/17/2013 |
SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM |
SD BIOSENSOR, INC. |
| K182738 |
09/28/2018 |
Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick |
Hangzhou AllTest Biotech Co., Ltd |
| K123090 |
10/01/2012 |
GLB BENECHECK PREMIUM GLU MONITORING SYSTEM |
GENERAL LIFE BIOTECHNOLOGY CO., LTD. |
| K113007 |
10/07/2011 |
BIONIME DIABETES MANAGEMENT SYSTEM VI.0 |
BIONIME CORPORATION |
| K133522 |
11/15/2013 |
RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM |
BIONIME COPORATION |
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