510(k) K810948
K810948 is an FDA 510(k) premarket notification submitted by Endocrine-Metabolic Center for the device "RADIOIMMUNOASSAY THYROID STIM. HORM. KIT". The FDA issued a decision of Substantially Equivalent on Apr 17, 1981. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Endocrine-Metabolic Center has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 17, 1981
- Date Received
- Apr 7, 1981
- 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)