Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Affymetrix, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| DEN130018 | CYTOSCAN(R) DX | Affymetrix, Inc. | 2014-01-17 | 30 | 0 |
| K103112 | AFFYMETRIX GENE PROFILING REAGENTS | Affymetrix, Inc. | 2011-05-04 | 195 | 0 |
| K080995 | MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATI | Affymetrix, Inc. | 2008-07-30 | 114 | 0 |
| DEN040012 | AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM | Affymetrix, Inc. | 2004-12-23 | 50 | 0 |
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