510(k) K780671
K780671 is an FDA 510(k) premarket notification submitted by Radioimmunoassay, Inc. for the device "125 I-T3 UPTAKE REAGENT". The FDA issued a decision of Substantially Equivalent on Jun 6, 1978. The device falls under product code CEE (Radioimmunoassay, Thyroxine-Binding Globulin), a Class II device regulated under 21 CFR 862.1685. Radioimmunoassay, Inc. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 6, 1978
- Date Received
- Apr 24, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Radioimmunoassay, Thyroxine-Binding Globulin
- Device Class
- Class II
- Regulation Number
- 862.1685
- Review Panel
- CH
- Submission Type
- 510(k) Exempt