FDA applicant
Alere, San Diego, Dba Biosite INcorporated, Dba IN
FDA records 1 decision for Alere, San Diego, Dba Biosite INcorporated, Dba IN (San Diego, CA) in 2010: 1 510(k) clearance. All are in product code JJY (Multi-Analyte Controls, All Kinds (Assayed)). Its devices cite 1 predicate, 0 of them its own earlier devices. 3 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Alere, San Diego, Dba Biosite INcorporated, Dba IN’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2026 so far, outlined.
Recalls per year
1in 2015
Class I Class II/III not classified
Planning a device like Alere, San Diego, Dba Biosite…’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) ReportOther applicant names beginning “Alere”
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