510(k) K780499
K780499 is an FDA 510(k) premarket notification submitted by Clinical Bioresearch for the device "CBR-T3RIA KIT". The FDA issued a decision of Substantially Equivalent on May 4, 1978. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Clinical Bioresearch has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 1978
- Date Received
- March 28, 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