JZR · Support Gels
Immunology · 21 CFR 866.4900 · Class 1
Overview
| Product Code | JZR |
|---|---|
| Device Name | Support Gels |
| Regulation | 21 CFR 866.4900 |
| Device Class | Class 1 |
| Review Panel | Immunology |
Identification
A support gel for clinical use is a device that consists of an agar or agarose preparation that is used while measuring various kinds of, or parts of, protein molecules by various immunochemical techniques, such as immunoelectrophoresis, immunodiffusion, or chromatography.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K940037 | I.D. AND SEAKEM GTG AGAROSES | Fmc Corp. | Feb 24, 1995 | SESE |
| K831603 | TITAN GE/IEPLATE | Helena Laboratories | Jul 7, 1983 | SESE |
Top Applicants
- Fmc Corp. — 1 clearance
- Helena Laboratories — 1 clearance
