Greer Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 2
- Inspections
- 11
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0347-2023 | Class II | GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS t | October 25, 2022 |
| Z-0348-2023 | Class II | GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIV | October 25, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K003195 | GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC | December 13, 2000 |
| K890360 | GREER DERMAPIK SYSTEM | June 23, 1989 |