510(k) K885195
K885195 is an FDA 510(k) premarket notification submitted by Amersham Corp. for the device "AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT". The FDA issued a decision of Substantially Equivalent on February 8, 1989. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Amersham Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 1989
- Date Received
- December 16, 1988
- 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