IGC — Formalin-Saline Class I
FDA Device Classification
Classification Details
- Product Code
- IGC
- Device Class
- Class I
- Regulation Number
- 864.4010
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K955363 | incstar | INCSTAR HSZ I/II IGG ELISA ASSAY | July 24, 1996 |
| K955362 | incstar | INCSTAR HSV I/II IGG FAST ELISA ASSAY | July 24, 1996 |