JHC — Acid, Uric, Uricase (Oxygen Rate) Class I
FDA product code JHC covers "Acid, Uric, Uricase (Oxygen Rate)", a Class I medical device regulated under 21 CFR 862.1775. 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
- JHC
- Device Class
- Class I
- Regulation Number
- 862.1775
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K863287 | catachem | URIC ACID (URICASE) METHOD-II | September 29, 1986 |