510(k) K885034
K885034 is an FDA 510(k) premarket notification submitted by Diamedix Corp. for the device "T-UPTAKE MICROASSAY". The FDA issued a decision of Substantially Equivalent on February 2, 1989. The device falls under product code CEE (Radioimmunoassay, Thyroxine-Binding Globulin), a Class II device regulated under 21 CFR 862.1685. Diamedix Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 1989
- Date Received
- December 5, 1988
- 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