FDA applicant
Handae Chemical Co., Ltd.
FDA records 1 decision for Handae Chemical Co., Ltd. (Jincheon-Gun,Chungcheongbuk-Do, KR) in 2004: 1 510(k) clearance. All are in product code ELW (Material, Impression). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Handae Chemical Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Handae Chemical Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Handae Chemical Co., Ltd.’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