FDA applicant
Tianjin New Bay Bioresearch Co., Ltd.
FDA records 11 decisions for Tianjin New Bay Bioresearch Co., Ltd. (Carlsbad, CA) from 2005 to 2013: 11 510(k) clearances. Most are in product codes DJG (Enzyme Immunoassay, Opiates) and DKZ (Enzyme Immunoassay, Amphetamine). Its devices cite 12 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tianjin New Bay Bioresearch Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2013
2026 so far, outlined.
Recalls per year
2in 2011
Class I Class II/III not classified
Planning a device like Tianjin New Bay Bioresearch 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