510(k) K792154
K792154 is an FDA 510(k) premarket notification submitted by Radioimmunoassay, Inc. for the device "THYROID STIMULATING HORMONE". The FDA issued a decision of Substantially Equivalent on Nov 13, 1979. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Radioimmunoassay, Inc. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 13, 1979
- Date Received
- Oct 25, 1979
- 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)