Affymetrix, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Affymetrix, Inc.” (first 2008, latest 2011), plus 2 De Novo decisions, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 154 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NSU | Instrumentation For Clinical Multiplex Test Systems | 2 | 1 |
| OVA | Complete Gene Expression Profiling Accessory Reagents | 1 | 1 |
| PFX | System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection | 1 | 0 |
Review panels
- Clinical Chemistry (3)
- Pathology (1)
Most recent Affymetrix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103112 | AFFYMETRIX GENE PROFILING REAGENTS | OVA | 2011-05-04 | 195 |
| K080995 | MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM | NSU | 2008-07-30 | 114 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130018 | De Novo | System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection | 2014-01-17 |
| DEN040012 | De Novo | Instrumentation For Clinical Multiplex Test Systems | 2004-12-23 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2016-04-14.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Affymetrix, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Affymetrix, Inc.” (first 2008, latest 2011), plus 2 De Novo decisions, across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Affymetrix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Affymetrix, Inc. is 154 days.
Which FDA product codes appear under Affymetrix, Inc.?
The most frequent FDA product codes under this applicant name are NSU (Instrumentation For Clinical Multiplex Test Systems, 2); OVA (Complete Gene Expression Profiling Accessory Reagents, 1); PFX (System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection, 1).
Next steps
- See all 2 Affymetrix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NSU, Affymetrix, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.