Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen · Predicate Candidate Screening
1 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120615 | ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PR | Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen | 2013-05-15 | 441 | 2 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda