Iso-Tex Diagnostics, Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 3
- Inspections
- 11
- Compliance Actions
- 3
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-1136-2019 | Class II | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for | April 15, 2019 |
| D-1008-2019 | Class II | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for | March 11, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K851389 | APO B RIA KIT | July 10, 1985 |
| K840105 | APO A-I RIA KIT-HUMAN PLASMA APOLIP- | January 10, 1984 |
| K782081 | RIA SYSTEM, PARATHYROID HORMONE | March 21, 1979 |