510(k) Report

FDA applicant

Chromatics Color Sciences Intl., Inc.

Rockville, MD2 decisions1997–20010 recalls

FDA records 2 decisions for Chromatics Color Sciences Intl., Inc. (Rockville, MD) from 1997 to 2001: 2 510(k) clearances. All are in product code MQM (Bilirubin (Total And Unbound) In The Neonate…). 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, clinical chemistry panel, where it files most

How often FDA has decided Chromatics Color Sciences Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Chromatics Color Sciences Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Chromatics Color Sciences Intl., 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?

  • MQMBilirubin (Total And Unbound) In The Neonate Test System2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K964590Colormate IiiChromatics Color Sciences Intl., Inc. · 19971cites it

What has FDA decided for it lately?

  • K001687Colormate TLC Bilitest SystemChromatics Color Sciences Intl., Inc. · 2001
  • K964590Colormate IiiChromatics Color Sciences Intl., Inc. · 1997

All 2 as Chromatics Color Sciences Intl., Inc. →