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Boston Biomedica, Inc.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K032713 BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGGLSR2003-11-24 View
510(k) K980351 BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KITLSR1999-03-05 View
510(k) K974811 ACCURUN(TM) 150 HSV IGG POSITIVE CONTROLJJX1998-02-10 View
510(k) K974810 ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROLLSR1998-02-05 View
510(k) K974809 ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROLLSR1998-02-05 View
510(k) K974261 ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROLLJK1997-12-11 View
510(k) K972986 ACCURUN 140 RUBELLA IGG POSITIVE CONTROLMJX1997-10-08 View
510(k) K972884 ACCURUN 146 CMV IGM POSITIVE CONTROLLKQ1997-08-22 View
510(k) K971657 ACCURUN 121 HAV IGM POSITIVE CONTROLJJY1997-08-12 View
510(k) K972048 ACCURUN 117 HBEAG POSITIVE CONTROLJJY1997-08-12 View
510(k) K972307 ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROLJJY1997-08-07 View
510(k) K971406 ACCURUN 120 HAV IGG POSITIVE CONTROLJJY1997-08-07 View
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