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Boston Biomedica, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K032713BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGGNovember 24, 2003
K980351BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KITMarch 5, 1999
K974811ACCURUN(TM) 150 HSV IGG POSITIVE CONTROLFebruary 10, 1998
K974810ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROLFebruary 5, 1998
K974809ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROLFebruary 5, 1998
K974261ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROLDecember 11, 1997
K972986ACCURUN 140 RUBELLA IGG POSITIVE CONTROLOctober 8, 1997
K972884ACCURUN 146 CMV IGM POSITIVE CONTROLAugust 22, 1997
K971657ACCURUN 121 HAV IGM POSITIVE CONTROLAugust 12, 1997
K972048ACCURUN 117 HBEAG POSITIVE CONTROLAugust 12, 1997
K971406ACCURUN 120 HAV IGG POSITIVE CONTROLAugust 7, 1997
K972307ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROLAugust 7, 1997