Affinity Biologicals, Inc.: FDA clearances and approvals
Affinity Biologicals, Inc. has 5 FDA 510(k) clearances (first 2005, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time: 180 days.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Affinity Biologicals, Inc. have?
Affinity Biologicals, Inc. has 5 FDA 510(k) clearances (first 2005, latest 2016), across 2 product codes in 1 review panel.
How long does FDA take to clear Affinity Biologicals, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Affinity Biologicals, Inc.'s cleared 510(k)s is 180 days.
What devices does Affinity Biologicals, Inc. make?
Its most frequent FDA product codes are GGN (Plasma, Coagulation Control, 3); GGP (Test, Qualitative And Quantitative Factor Deficiency, 2).
Has Affinity Biologicals, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Affinity Biologicals, Inc. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.