FDA applicant
Co-Innovation Biotech Co., Ltd.
FDA records 10 decisions for Co-Innovation Biotech Co., Ltd. (Guangzhou, CN) from 2013 to 2024: 10 510(k) clearances. Most are in product codes DJG (Enzyme Immunoassay, Opiates) and DKZ (Enzyme Immunoassay, Amphetamine). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 4 of them its own earlier devices. 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 Co-Innovation Biotech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Co-Innovation Biotech 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