Ansh Labs, LLC: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Ansh Labs, LLC”, 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 |
|---|---|---|---|
| QDH | Menopause Test System | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180004 | De Novo | Menopause Test System | 2018-10-24 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-12-18.
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 Ansh Labs, LLC?
FDA lists 0 510(k) clearances under the applicant name “Ansh Labs, LLC”, 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 Ansh Labs, LLC?
The most frequent FDA product codes under this applicant name are QDH (Menopause Test System, 1).
Next steps
- See all 0 Ansh Labs, LLC clearances with predicates and recalls
- Run predicate analysis for product code QDH, Ansh Labs, LLC'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.