FDA applicant

Diamond Diagnostics, Inc.

Holliston, MA26 decisions2001–20201 recall

FDA records 26 decisions for Diamond Diagnostics, Inc. (Holliston, MA) from 2001 to 2020: 26 510(k) clearances. Most are in product codes JIT (Calibrator, Secondary) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). Its devices cite 36 predicates, 6 of them its own earlier devices. 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, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2020

2007high 4 (2012) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2019

2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Diamond Diagnostics, 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 “Diamond”

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

Diamond Medical, Inc. 6 Diamond Sensor Systems 3 Diamond Medical Equipment, Inc. 3 Diamond Shamrock Corp. 2 Diamond Electro-Tech, Inc. 1 Diamond Orthopedic, LLC 1 Diamond Rotary and Carbide Intl. 1 Diamond Systems USA, Inc. 1 Diamond Age Systems, Inc. 1 Diamond General Development Corp. 1 Diamond Orthotic Laboratory 1 Diamond Mark International Co., Ltd. 1

Diamond Diagnostics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Diamond”