510(k) K181082
K181082 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)". The FDA issued a decision of Substantially Equivalent on May 25, 2018. The device falls under product code NDY (Test, Cystatin C), a Class II device regulated under 21 CFR 862.1225. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 2018
- Date Received
- April 24, 2018
- 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