510(k) K121951

LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 by DiaSorin, Inc. — Product Code CEC

K121951 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3". The FDA issued a decision of Substantially Equivalent on April 4, 2013. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2013
Date Received
July 3, 2012
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