510(k) K080167
K080167 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS". The FDA issued a decision of Substantially Equivalent on August 8, 2008. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2008
- Date Received
- January 23, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Free Thyroxine
- Device Class
- Class II
- Regulation Number
- 862.1695
- Review Panel
- CH
- Submission Type