510(k) K910677
K910677 is an FDA 510(k) premarket notification submitted by Cirrus Diagnostics, Inc. for the device "IMMULITE(TM) T-UPTAKE". The FDA issued a decision of Substantially Equivalent on April 29, 1991. The device falls under product code CEE (Radioimmunoassay, Thyroxine-Binding Globulin), a Class II device regulated under 21 CFR 862.1685. Cirrus Diagnostics, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1991
- Date Received
- February 15, 1991
- 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