Nowdiagnostics: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Nowdiagnostics”, 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 |
|---|---|---|---|
| SBZ | Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users | 1 | 0 |
Review panels
- Microbiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230090 | De Novo | Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users | 2024-08-16 |
Recalls
openFDA lists no recalls under a recalling firm named Nowdiagnostics.
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.
Device clinical trials
An industry sponsor named Nowdiagnostics is the lead sponsor of 3 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07304531: First To Know Pregnancy Test - Clinical Evaluation Protocol (Recruiting, started 2025-10-14)
- NCT05063344: NOWDx Test for the Diagnosis of Syphilis (Completed, started 2021-10-04)
- NCT04690413: NOWDx Test for the Detection of Antibodies to COVID-19 (Completed, started 2020-09-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nowdiagnostics?
FDA lists 0 510(k) clearances under the applicant name “Nowdiagnostics”, 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 Nowdiagnostics?
The most frequent FDA product codes under this applicant name are SBZ (Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users, 1).
Next steps
- See all 0 Nowdiagnostics clearances with predicates and recalls
- Run predicate analysis for product code SBZ, Nowdiagnostics'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.