FDA applicant
Lin-Zhi International, Inc.
FDA records 50 decisions for Lin-Zhi International, Inc. (Synnyvale, CA) from 2002 to 2026: 49 510(k) clearances and 1 De Novo grant. Most are in product codes DJG (Enzyme Immunoassay, Opiates) and DKZ (Enzyme Immunoassay, Amphetamine). Since 2016 its 510(k)s took a median of 44 days from receipt to decision, against 31 for FDA’s reviews in the same codes and years. Its devices cite 67 predicates, 35 of them its own earlier devices. 10 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Lin-Zhi International, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
3in 2019
Class I Class II/III not classified
Planning a device like Lin-Zhi International, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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