FDA 510(k) Applications Submitted by PATRICIA E GARRETT
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K971406 |
04/16/1997 |
ACCURUN 120 HAV IGG POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
| K971657 |
05/06/1997 |
ACCURUN 121 HAV IGM POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
| K972048 |
06/02/1997 |
ACCURUN 117 HBEAG POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
| K972307 |
06/19/1997 |
ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
| K972884 |
08/05/1997 |
ACCURUN 146 CMV IGM POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
| K972986 |
08/11/1997 |
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
| K032713 |
09/02/2003 |
BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG |
BOSTON BIOMEDICA, INC. |
| K974261 |
11/13/1997 |
ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
| K974809 |
12/23/1997 |
ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
| K974810 |
12/23/1997 |
ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
| K974811 |
12/23/1997 |
ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
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