510(k) K870245

AUTOPAK TSH MONOCLONAL IRMA KIT by Micromedic Systems — Product Code JLW

K870245 is an FDA 510(k) premarket notification submitted by Micromedic Systems for the device "AUTOPAK TSH MONOCLONAL IRMA KIT". The FDA issued a decision of Substantially Equivalent on April 1, 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.