510(k) K905214
K905214 is an FDA 510(k) premarket notification submitted by Cirrus Diagnostics, Inc. for the device "IMMULITE (TM) TOTAL T3". The FDA issued a decision of Substantially Equivalent on February 1, 1991. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Cirrus Diagnostics, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1991
- Date Received
- November 20, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Total Triiodothyronine
- Device Class
- Class II
- Regulation Number
- 862.1710
- Review Panel
- CH
- Submission Type