FDA applicant
Chemtron Biotech, Inc.
FDA records 11 decisions for Chemtron Biotech, Inc. (San Diego, CA) from 2011 to 2023: 11 510(k) clearances. Most are in product codes DJG (Enzyme Immunoassay, Opiates) and DKZ (Enzyme Immunoassay, Amphetamine). Its devices cite 18 predicates, 7 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 Chemtron Biotech, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Chemtron Biotech, 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