Affinity Biologicals, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Affinity Biologicals, Inc.” (first 2005, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 180 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 | 1 | 409 |
| 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 |
|---|---|---|---|
| GGN | Plasma, Coagulation Control | 3 | 3 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 2 | 2 |
Review panels
- Hematology (5)
Most recent Affinity Biologicals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150144 | VisuCon-F Low Fibrinogen Control Plasma | GGN | 2016-03-06 | 409 |
| K110432 | VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN | GGN | 2011-10-20 | 247 |
| K091284 | VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA | GGN | 2009-10-28 | 180 |
| K052825 | VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG | GGP | 2006-01-20 | 107 |
| K051054 | VISULIZE FACTOR IX ANTIGEN KIT | GGP | 2005-06-29 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Affinity Biologicals, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Affinity Biosensors, LLC (3 510(k)s)
- Affinity Medical Technologies, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Affinity Biologicals, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Affinity Biologicals, Inc.” (first 2005, latest 2016), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Affinity Biologicals, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Affinity Biologicals, Inc. is 180 days.
Which FDA product codes appear under Affinity Biologicals, Inc.?
The most frequent FDA product codes under this applicant name are GGN (Plasma, Coagulation Control, 3); GGP (Test, Qualitative And Quantitative Factor Deficiency, 2).
Next steps
- See all 5 Affinity Biologicals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GGN, Affinity Biologicals, 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.