510(k) K781560
K781560 is an FDA 510(k) premarket notification submitted by Nuclear Diagnostics, Inc. for the device "RIA DIAG. TEST KIT FOR INDEXING THYROX.". The FDA issued a decision of Substantially Equivalent on October 17, 1978. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Nuclear Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 1978
- Date Received
- September 11, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Free Thyroxine
- Device Class
- Class II
- Regulation Number
- 862.1695
- Review Panel
- CH
- Submission Type