FDA applicant

Crystal Diagnostics, Inc.

Woburn, MA2 decisions1990–19910 recalls

FDA records 2 decisions for Crystal Diagnostics, Inc. (Woburn, MA) from 1990 to 1991: 2 510(k) clearances. All are in product code CHH (Enzymatic Esterase--Oxidase, Cholesterol). 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 Crystal Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Crystal 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 “Crystal”

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

Crystal Medical Products, Inc. 5 Crystal Medical Technology 2 Crystal Optical Co., Ltd. 1 Crystal Reflections, Int., Inc. 1 Crystal Care Intl., Inc. 1 Crystal Tone Hearing Instruments 1 Crystal Medtech, LLC 1 Crystal Mark, Inc. 1 Crystal-Seal Dental Implants 1

Crystal Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Crystal”