510(k) K854379

MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT by Bioclinical Systems, Inc. — Product Code JLW

K854379 is an FDA 510(k) premarket notification submitted by Bioclinical Systems, Inc. for the device "MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT". The FDA issued a decision of Substantially Equivalent on January 7, 1986. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Bioclinical Systems, Inc. has at least 10 other 510(k) clearances on record.