510(k) K152422
K152422 is an FDA 510(k) premarket notification submitted by Nanoentek USA, Inc. for the device "FREND Free T4 Test System". The FDA issued a decision of Substantially Equivalent on February 17, 2016. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Nanoentek USA, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2016
- Date Received
- August 26, 2015
- 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