Artann Laboratories, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Artann Laboratories, Inc.”, 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 |
|---|---|---|---|
| OQT | Prostate Lesion, Documentation, System | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN100016 | De Novo | Prostate Lesion, Documentation, System | 2012-04-27 |
Recalls
openFDA lists no recalls under a recalling firm named Artann Laboratories, Inc..
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 Artann Laboratories, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02206633: Hydration Monitor Validation in Elderly (Completed, started 2014-11)
- NCT02206581: Using Hydration Monitor to Detect Changes in the Hydration Status Athletes (Completed, started 2014-10)
- NCT02101099: Effect of Anesthesia on Force Application During Colonoscopy (Completed, started 2014-03)
- NCT01123421: Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment (Completed, started 2010-05)
Frequently asked questions
How many FDA 510(k) clearances are listed under Artann Laboratories, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Artann Laboratories, Inc.”, 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 Artann Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are OQT (Prostate Lesion, Documentation, System, 1).
Next steps
- See all 0 Artann Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OQT, Artann Laboratories, Inc.'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.