510(k) K093680
K093680 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME CYSTATIN C ASSAY". The FDA issued a decision of Substantially Equivalent on April 8, 2010. The device falls under product code NDY (Test, Cystatin C), a Class II device regulated under 21 CFR 862.1225. Diazyme Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2010
- Date Received
- November 27, 2009
- Clearance Type
- Traditional
- 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