510(k) K771234
K771234 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "TSH RIA REAGENT SET". The FDA issued a decision of Substantially Equivalent on Oct 18, 1977. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. G.D. Searle And Co. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 18, 1977
- Date Received
- Jul 11, 1977
- 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
- 510(k)