510(k) K770677
K770677 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "T-3 RIA REAGENT SET". The FDA issued a decision of Substantially Equivalent on May 20, 1977. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. G.D. Searle And Co. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 1977
- Date Received
- Apr 11, 1977
- 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
- 510(k) Exempt