510(k) K884753
K884753 is an FDA 510(k) premarket notification submitted by Advanced Magnetics, Inc. for the device "MODIFIED FREE T4 RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on February 27, 1989. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Advanced Magnetics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 1989
- Date Received
- November 14, 1988
- 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