510(k) K822684
K822684 is an FDA 510(k) premarket notification submitted by Immunotech Corp. for the device "ENDAB THYROID UPTAKE". The FDA issued a decision of Substantially Equivalent on October 8, 1982. The device falls under product code CEE (Radioimmunoassay, Thyroxine-Binding Globulin), a Class II device regulated under 21 CFR 862.1685. Immunotech Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 1982
- Date Received
- September 3, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Thyroxine-Binding Globulin
- Device Class
- Class II
- Regulation Number
- 862.1685
- Review Panel
- CH
- Submission Type