Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SAC | Adamts13 Activity Test System | 1 | 0 |
Review panels
- Hematology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230024 | De Novo | Adamts13 Activity Test System | 2024-02-28 |
Recalls
openFDA lists no recalls under a recalling firm named Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM.
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 Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM?
FDA lists 0 510(k) clearances under the applicant name “Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM?
The most frequent FDA product codes under this applicant name are SAC (Adamts13 Activity Test System, 1).
Next steps
- See all 0 Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM clearances with predicates and recalls
- Run predicate analysis for product code SAC, Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM'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.