FDA applicant
Quantech, Ltd.
FDA records 3 decisions for Quantech, Ltd. (Northridge, CA) from 1999 to 2002: 3 510(k) clearances. Most are in product codes NAL (Test, Immunoassay, Biosensor, Hcg) and MYT (Biosensor, Immunoassay, Cpk Or Isoenzymes). 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 Quantech, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Quantech, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Quantech, 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