# Boston Biomedica, Inc.

- Location (FDA's records): West Bridgewater, MA
- FDA decisions: 12 (1997–2003): 12 510(k) clearances
- Product codes: LSR (4), JJY (4), LJK (1), MJX (1), LKQ (1), JJX (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mardx Diagnostics, Inc.: 2 (https://510kreport.com/company/mardx-diagnostics)

## Recent decisions
- K032713: Boston Biomedica, Inc. Borrelia Burgdorferi Igm and Igg (Nov 24, 2003)
- K980351: Bbi-Biotech Research Laboratories B. Burgdorferi Igm Western Blot Kit (Mar 5, 1999)
- K974811: Accurun (TM) 150 HSV Igg Positive Control (Feb 10, 1998)
- K974809: Accurun (TM) 130 Borrelia Burgdorferi Igg Positive Control (Feb 5, 1998)
- K974810: Accurun (TM) 132 Borrelia Burdorferi Igm Positive Control (Feb 5, 1998)
- K974261: Accurun 135 Toxoplasma Igg Positive Control (Dec 11, 1997)
- K972986: Accurun 140 Rubella Igg Positive Control (Oct 8, 1997)
- K972884: Accurun 146 CMV Igm Positive Control (Aug 22, 1997)

Source page: https://510kreport.com/company/boston-biomedica