510(k) K792443

TSH RADIOIMMUNOASSAY by Dade, Baxter Travenol Diagnostics, Inc. — Product Code JLW

K792443 is an FDA 510(k) premarket notification submitted by Dade, Baxter Travenol Diagnostics, Inc. for the device "TSH RADIOIMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on December 27, 1979. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Dade, Baxter Travenol Diagnostics, Inc. has at least 10 other 510(k) clearances on record.