510(k) K131928
K131928 is an FDA 510(k) premarket notification submitted by Nanoentek USA, Inc. for the device "FREND TSH (REAGENT CARTRIDGE)". The FDA issued a decision of Substantially Equivalent on March 14, 2014. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Nanoentek USA, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2014
- Date Received
- June 27, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Thyroid-Stimulating Hormone
- Device Class
- Class II
- Regulation Number
- 862.1690
- Review Panel
- CH
- Submission Type