JGE — Turbidimetric Method, Globulin Class I
FDA product code JGE covers "Turbidimetric Method, Globulin", a Class I medical device regulated under 21 CFR 862.1330. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- JGE
- Device Class
- Class I
- Regulation Number
- 862.1330
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K980055 | exigent diagnostics | CARESIDE GLOBULIN | January 28, 1998 |