Hana Biologics, Inc.: FDA clearances and approvals
Hana Biologics, Inc. has 8 FDA 510(k) clearances (first 1981, latest 1988), across 4 product codes in 3 review panels. Median 510(k) review time: 85 days.
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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | 3 | 3 |
| JHG | Chromatographic Separation, Lecithin/Sphingomyelin Ratio | 2 | 2 |
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 2 | 2 |
| KQN | Radioassay, Angiotensin Converting Enzyme | 1 | 1 |
Review panels
- Clinical Chemistry (3)
- Microbiology (3)
- Pathology (2)
Most recent Hana Biologics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883682 | CHANG MEDIUM (ADDITIONAL INDICATIONS) | KIT | 1988-09-16 | 18 |
| K855205 | MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM | JSI | 1986-02-05 | 37 |
| K834616 | AMNIO STAT-FLM AGGLUTINATION TEST | JHG | 1984-05-25 | 163 |
| K833933 | ACE COLOR TEST | KQN | 1984-03-23 | 130 |
| K822737 | MYCOTRIUM-RS | JSI | 1982-12-03 | 85 |
| K822736 | MYCOTRIUM-GU | JSI | 1982-12-03 | 85 |
| K822150 | AMNISTAT-FLM | JHG | 1982-10-21 | 91 |
| K812820 | CHANG MEDIUM | KIT | 1981-11-10 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named Hana Biologics, 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 Hana Biologics, Inc. have?
Hana Biologics, Inc. has 8 FDA 510(k) clearances (first 1981, latest 1988), across 4 product codes in 3 review panels.
How long does FDA take to clear Hana Biologics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hana Biologics, Inc.'s cleared 510(k)s is 85 days.
What devices does Hana Biologics, Inc. make?
Its most frequent FDA product codes are JSI (Culture Media, Selective And Differential, 3); JHG (Chromatographic Separation, Lecithin/Sphingomyelin Ratio, 2); KIT (Media And Components, Synthetic Cell And Tissue Culture, 2).
Has Hana Biologics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hana Biologics, Inc. Related entities may recall under other names.
Next steps
- See all 8 Hana Biologics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSI, Hana Biologics, 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.