510(k) K920442

IMMUCHEM TSH-MW ELISA by Icn Biomedicals, Inc. — Product Code JLW

K920442 is an FDA 510(k) premarket notification submitted by Icn Biomedicals, Inc. for the device "IMMUCHEM TSH-MW ELISA". The FDA issued a decision of Substantially Equivalent on March 18, 1992. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Icn Biomedicals, Inc. has at least 10 other 510(k) clearances on record.