510(k) K860813

MICROMEDIC HTSH MONOCLONAL IRMA KIT by Micromedic Systems — Product Code JLW

K860813 is an FDA 510(k) premarket notification submitted by Micromedic Systems for the device "MICROMEDIC HTSH MONOCLONAL IRMA KIT". The FDA issued a decision of Substantially Equivalent on July 14, 1986. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Micromedic Systems has at least 10 other 510(k) clearances on record.