Boston Biomedica, Inc. is one of 8019 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Boston Biomedica, Inc. - FDA 510(k) Cleared Devices
Recent clearances: BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT, ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL, ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
12
Total
12
Cleared
0
Denied
Boston Biomedica, Inc. has 12 FDA 510(k) cleared microbiology devices. Based in West Bridgewater, US.
Historical record: 12 cleared submissions from 1997 to 2003.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Boston Biomedica, Inc.
12 devices
Cleared
Nov 24, 2003
BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
Microbiology
83d
Cleared
Mar 05, 1999
BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
Microbiology
400d
Cleared
Feb 10, 1998
ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL
Microbiology
49d
Cleared
Feb 05, 1998
ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
Microbiology
44d
Cleared
Feb 05, 1998
ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
Microbiology
44d
Cleared
Dec 11, 1997
ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL
Microbiology
28d
Cleared
Oct 08, 1997
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
Microbiology
58d
Cleared
Aug 22, 1997
ACCURUN 146 CMV IGM POSITIVE CONTROL
Microbiology
17d
Cleared
Aug 12, 1997
ACCURUN 121 HAV IGM POSITIVE CONTROL
Microbiology
98d
Cleared
Aug 12, 1997
ACCURUN 117 HBEAG POSITIVE CONTROL
Microbiology
71d
Cleared
Aug 07, 1997
ACCURUN 120 HAV IGG POSITIVE CONTROL
Microbiology
113d
Cleared
Aug 07, 1997
ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL
Microbiology
49d