510(k) K081875
K081875 is an FDA 510(k) premarket notification submitted by Gentian AS for the device "GENTIAN CYSTATIN C IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on August 20, 2008. The device falls under product code NDY (Test, Cystatin C), a Class II device regulated under 21 CFR 862.1225. Gentian AS has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 2008
- Date Received
- July 2, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Cystatin C
- Device Class
- Class II
- Regulation Number
- 862.1225
- Review Panel
- CH
- Submission Type