510(k) K161494
K161494 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)". The FDA issued a decision of Substantially Equivalent on November 15, 2016. The device falls under product code CGX (Alkaline Picrate, Colorimetry, Creatinine), 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
- November 15, 2016
- Date Received
- June 1, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alkaline Picrate, Colorimetry, Creatinine
- Device Class
- Class II
- Regulation Number
- 862.1225
- Review Panel
- CH
- Submission Type