510(k) K974027
K974027 is an FDA 510(k) premarket notification submitted by Alfa Biotech (Uk) , Ltd. for the device "AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK". The FDA issued a decision of Substantially Equivalent on February 2, 1998. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Alfa Biotech (Uk) , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 1998
- Date Received
- October 23, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Total Triiodothyronine
- Device Class
- Class II
- Regulation Number
- 862.1710
- Review Panel
- CH
- Submission Type