FDA applicant

Sealite Sciences, Inc.

Norcross, GA11 decisions1994–19970 recalls

FDA records 11 decisions for Sealite Sciences, Inc. (Norcross, GA) from 1994 to 1997: 11 510(k) clearances. Most are in product codes CEP (Radioimmunoassay, Luteinizing Hormone) and CGJ (Radioimmunoassay, Follicle-Stimulating Hormone). 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 Sealite Sciences, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sealite Sciences, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sealite Sciences, 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

Sealite Sciences, Inc.

Which product codes does it file in?

What has FDA decided for it lately?