FDA applicant

Statlabs, Inc.

Franklin, TN1 decision1989–198911 recalls

FDA records 1 decision for Statlabs, Inc. (Franklin, TN) in 1989: 1 510(k) clearance. All are in product code KZB (Automated Colony Counter). 11 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Statlabs, Inc. since 2007.

Recalls per year

11in 2008

2007high 11 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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Statlabs, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?