510(k) K851148
K851148 is an FDA 510(k) premarket notification submitted by Euro-Diagnostics BV for the device "TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE". The FDA issued a decision of Substantially Equivalent on April 29, 1985. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Euro-Diagnostics BV has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1985
- Date Received
- March 21, 1985
- 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