510(k) Report

FDA applicant

Richmond Diagnostics, Inc.

New Brunswick, NJ1 decision1997–19970 recalls

FDA records 1 decision for Richmond Diagnostics, Inc. (New Brunswick, NJ) in 1997: 1 510(k) clearance. All are in product code GLK (Control, Hematocrit). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Richmond Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Richmond 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

Which product codes does it file in?

  • GLKControl, Hematocrit1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K964452HematachekRichmond Diagnostics, Inc. · 19971cites it

What has FDA decided for it lately?

  • K964452HematachekRichmond Diagnostics, Inc. · 1997

The one decision as Richmond Diagnostics, Inc. →

Other applicant names beginning “Richmond”

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

Richmond Products, Inc. 15The Richmond Light Co. 2