510(k) K792539
K792539 is an FDA 510(k) premarket notification submitted by Radioimmunoassay, Inc. for the device "TRIIODOTHYRONINE RIA SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 16, 1980. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Radioimmunoassay, Inc. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 16, 1980
- Date Received
- Dec 10, 1979
- 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
- 510(k) Exempt