510(k) Report

FDA applicant

Cambridge Bioscience Corp.

Worcester, MA5 decisions1985–19891 recall

FDA records 5 decisions for Cambridge Bioscience Corp. (Worcester, MA) from 1985 to 1989: 5 510(k) clearances. Most are in product codes GOD (Antigens, Cf (Including Cf Control)…) and LSR (Reagent, Borrelia Serological Reagent). 1 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 Cambridge Bioscience Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cambridge Bioscience Corp. since 2007.

Recalls per year

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Other applicant names beginning “Cambridge”

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