FSC Laboratories, Inc
FDA Regulatory Profile
FSC Laboratories, Inc appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1995-2016, Class II) was initiated on May 16, 2016. Its most recent 510(k) clearance was granted on October 3, 2014.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1995-2016 | Class II | Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosoli | May 16, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K140062 | FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER | October 3, 2014 |