510(k) K971141
K971141 is an FDA 510(k) premarket notification submitted by Dade Chemistry Systems, Inc. for the device "FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 28, 1997. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Dade Chemistry Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 1997
- Date Received
- March 28, 1997
- 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