FDA applicant

Cell Analysis, Inc.

Evanston, IL1 decision2004–20041 recall

FDA records 1 decision for Cell Analysis, Inc. (Evanston, IL) in 2004: 1 510(k) clearance. All are in product code NQN (Microscope, Automated, Image Analysis…). Its devices cite 1 predicate, 0 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Cell Analysis, Inc. since 2007.

Recalls per year

1in 2008

2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Cell Analysis, 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 “Cell”

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

Cell Robotics, Inc. 9 Cell Constructs I, LLC 1 Cell Gen Therapeutics, LLC 1 Cell Bio-Systems, Inc. 1 Cell Ent., Inc. 1 Cell Culture Laboratories 1 Cell Store (Beijing) Biotechnology CO., LTD. 1

Cell Analysis, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Cell”