FDA applicant

Chroma Vision Medical Systems, Inc.

San Juan Capistrano, CA3 decisions1999–20030 recalls

FDA records 3 decisions for Chroma Vision Medical Systems, Inc. (San Juan Capistrano, CA) from 1999 to 2003: 3 510(k) clearances. Most are in product codes NOT (Microscope, Automated, Image Analysis…) and JOY (Device, Automated Cell-Locating). Its devices cite 1 predicate, 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, hematology panel, where it files most

How often FDA has decided Chroma Vision Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Chroma Vision Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Chroma”

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

Chroma Products, Inc. 1

Chroma Vision Medical Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Chroma”