510(k) K780672
K780672 is an FDA 510(k) premarket notification submitted by Radioimmunoassay, Inc. for the device "125 I-T4 RIA REAGENT". The FDA issued a decision of Substantially Equivalent on Jun 6, 1978. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Radioimmunoassay, Inc. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 6, 1978
- Date Received
- Apr 24, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Radioimmunoassay, Total Thyroxine
- Device Class
- Class II
- Regulation Number
- 862.1700
- Review Panel
- CH
- Submission Type
- 510(k) Exempt