510(k) K963833
K963833 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "IMX FREE TRIIODOTHYRONINE (FREE T3)". The FDA issued a decision of Substantially Equivalent on October 30, 1996. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 1996
- Date Received
- September 24, 1996
- 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