510(k) K130469

LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3 by DiaSorin, Inc. — Product Code JLW

K130469 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3". The FDA issued a decision of Substantially Equivalent on April 5, 2013. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.