FDA 510(k) Applications Submitted by BRUCE MACFARLANE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K010973 |
04/02/2001 |
DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000 |
HYPOGUARD USA, INC. |
| K033851 |
12/11/2003 |
DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) |
HYPOGUARD USA, INC. |
| K010039 |
01/05/2001 |
QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION |
CHRONIMED, INC. |
| K020232 |
01/14/2002 |
HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM |
HYPOGUARD USA, INC. |
| K011233 |
04/23/2001 |
MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 |
APEX BIOTECHNOLOGY CORP. |
| K031388 |
05/02/2003 |
MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM |
HYPOGUARD USA, INC. |
| K961810 |
05/10/1996 |
SUPPLE PERI-GUARD PERICARDIUM |
BIO-VASCULAR, INC. |
| K961811 |
05/10/1996 |
PERI-GUARD PERICARDIUM |
BIO-VASCULAR, INC. |
| K051514 |
06/08/2005 |
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002 |
HYPOGUARD USA, INC. |
| K041881 |
07/12/2004 |
ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100 |
HYPOGUARD USA, INC. |
| K022545 |
08/01/2002 |
GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 |
HYPOGUARD USA, INC. |
| K062799 |
09/19/2006 |
GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM |
APEX BIOTECHNOLOGY CORP. |
| K053079 |
11/02/2005 |
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 |
HYPOGUARD USA, INC. |
| K024347 |
12/30/2002 |
EXPRESS BLOOD GLUCOSE MONITORING SYSTEM |
HYPOGUARD USA, INC. |
| K963697 |
09/16/1996 |
ADVANCED DIAGNOSTIC VIEWER (ADV) |
BIO-VASCULAR, INC. |
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