FDA applicant

Cambridge Biotech Corp.

Rockville, MD3 decisions1991–19980 recalls

FDA records 3 decisions for Cambridge Biotech Corp. (Rockville, MD) from 1991 to 1998: 3 510(k) clearances. Most are in product codes LSR (Reagent, Borrelia Serological Reagent) and LLH (Reagents, Clostridium Difficile Toxin). 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 Cambridge Biotech Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cambridge Biotech Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Cambridge”

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

Cambridge Heart, Inc. 17 Cambridge Medical Technology 14 Cambridge Instruments, Inc. 13 Cambridge Medical Instruments, Inc. 8 Cambridge Bioscience Corp. 5 Cambridge Nuclear Corp. 5 Cambridge Chemical Products, Inc. 4 Cambridge Diagnostics Ireland, Ltd. 4 Cambridge Life Sciences Plc. 4 Cambridge Sensors Limited 3 Cambridge Scientific 2 Cambridge Technologies, Inc. 2

Cambridge Biotech Corp.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Cambridge”