FDA 510(k) Applications Submitted by HMD BIOMEDICAL, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140150 |
01/22/2014 |
Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System |
HMD BIOMEDICAL, INC. |
| K131173 |
04/25/2013 |
FIA Blood Glucose Monitoring System (G2) |
HMD BIOMEDICAL, INC. |
| K032985 |
09/24/2003 |
GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM |
HMD BIOMEDICAL, INC. |
| K023279 |
10/01/2002 |
GLUCOLEADER VALUE |
HMD BIOMEDICAL, INC. |
| K120064 |
01/09/2012 |
TEST, BLOOD GLUCOSE SYSTEM |
HMD BIOMEDICAL, INC. |
| K121433 |
05/14/2012 |
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS |
HMD BIOMEDICAL, INC. |
| K113307 |
11/08/2011 |
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM |
HMD BIOMEDICAL, INC. |
| K113314 |
11/09/2011 |
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM |
HMD BIOMEDICAL, INC. |
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