Bioptigen, Inc.
FDA Regulatory Profile
Bioptigen, Inc. appears in FDA public data with 0 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on December 9, 2016.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K162783 | EnFocus 2300, EnFocus 4400 | December 9, 2016 |
| K150722 | EnFocus 2300, EnFocus 4400 | December 2, 2015 |
| K120057 | ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) | May 11, 2012 |
| K063343 | BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM | December 13, 2006 |