510(k) K780018
K780018 is an FDA 510(k) premarket notification submitted by Clinical Immuno-Diagnostics for the device "THYRO-INDICATOR T-3 125I". The FDA issued a decision of Substantially Equivalent on February 7, 1978. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Clinical Immuno-Diagnostics has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1978
- Date Received
- January 3, 1978
- 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