510(k) K110761
K110761 is an FDA 510(k) premarket notification submitted by Magnabiosciences, LLC for the device "MICT TSH". The FDA issued a decision of Substantially Equivalent on March 9, 2012. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 2012
- Date Received
- March 18, 2011
- 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