510(k) K870904

MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT by Micromedic Systems — Product Code JLW

K870904 is an FDA 510(k) premarket notification submitted by Micromedic Systems for the device "MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT". The FDA issued a decision of Substantially Equivalent on May 26, 1987. 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.