FDA applicant

Boston Biomedica, Inc.

West Bridgewater, MA12 decisions1997–20030 recalls

FDA records 12 decisions for Boston Biomedica, Inc. (West Bridgewater, MA) from 1997 to 2003: 12 510(k) clearances. Most are in product codes LSR (Reagent, Borrelia Serological Reagent) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Boston Biomedica, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Boston Biomedica, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Boston Biomedica, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Boston Biomedica, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Boston”

FDA records each applicant name separately; these may or may not be the same firm.

Boston Scientific Corp 809 Boston Scientific Scimed, Inc. 40 Boston Medical Products, Inc. 33 Boston Scientific, Target 19 Boston Surgical Products, Inc. 17 Boston Scientific Neuromodulation 11 Boston Pacific Medical, Inc. 11 Boston Medical Corp. 8 Boston Aesthetics, Inc. 6 The Boston Medical Group 5 Boston Scientific/Medi-Tech 5 Boston Scientific /International Technologies 5

Boston Biomedica, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Boston”