510(k) K914756

ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT by Medix Biotech, Inc. — Product Code JLW

K914756 is an FDA 510(k) premarket notification submitted by Medix Biotech, Inc. for the device "ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT". The FDA issued a decision of Substantially Equivalent on January 15, 1992. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Medix Biotech, Inc. has at least 10 other 510(k) clearances on record.