510(k) K082638
K082638 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL". The FDA issued a decision of Substantially Equivalent on February 26, 2009. The device falls under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 2009
- Date Received
- September 10, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- Device Class
- Class II
- Regulation Number
- 862.1700
- Review Panel
- CH
- Submission Type