Medical Device Manufacturer · US , West Bridgewater , MA

Boston Biomedica, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1997
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.

12 devices
1–12 of 12
BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
K032713 · LSR Reagent, Borrelia Serological Reagent · Microbiology
Nov 2003 83d
BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
K980351 · LSR Reagent, Borrelia Serological Reagent · Microbiology
Mar 1999 400d
ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL
K974811 · JJX Single (specified) Analyte Controls (assayed And Unassayed) · Microbiology
Feb 1998 49d
ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
K974809 · LSR Reagent, Borrelia Serological Reagent · Microbiology
Feb 1998 44d
ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
K974810 · LSR Reagent, Borrelia Serological Reagent · Microbiology
Feb 1998 44d
ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL
K974261 · LJK Antisera, If, Toxoplasma Gondii · Microbiology
Dec 1997 28d
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
K972986 · MJX Kit, Serological, Positive Control · Microbiology
Oct 1997 58d
ACCURUN 146 CMV IGM POSITIVE CONTROL
K972884 · LKQ Antibody Igm,if, Cytomegalovirus Virus · Microbiology
Aug 1997 17d
ACCURUN 121 HAV IGM POSITIVE CONTROL
K971657 · JJY Multi-analyte Controls, All Kinds (assayed) · Microbiology
Aug 1997 98d
ACCURUN 117 HBEAG POSITIVE CONTROL
K972048 · JJY Multi-analyte Controls, All Kinds (assayed) · Microbiology
Aug 1997 71d
ACCURUN 120 HAV IGG POSITIVE CONTROL
K971406 · JJY Multi-analyte Controls, All Kinds (assayed) · Microbiology
Aug 1997 113d
ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL
K972307 · JJY Multi-analyte Controls, All Kinds (assayed) · Microbiology
Aug 1997 49d
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