Acs 180 and Advia Centaur FT4 Immunoassays
FDA 510(k) K080167 · Siemens Healthcare Diagnostics
510(k) numberK080167
Submission
- Device name
- Acs 180 and Advia Centaur FT4 Immunoassays
- Applicant
- Siemens Healthcare Diagnostics
Tarrytown, NY, US - Received
- January 23, 2008
- Decision date
- August 8, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CEC – Radioimmunoassay, Free Thyroxine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1695
- Specialty
- Clinical Chemistry
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Questions and answers
When was Acs 180 and Advia Centaur FT4 Immunoassays cleared by the FDA?
Acs 180 and Advia Centaur FT4 Immunoassays (K080167) received a 510(k) decision of Substantially Equivalent on August 8, 2008, 198 days after the submission was received.
What is the product code of K080167?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.