510(k) K001606

REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107) by Repromedix Corp. — Product Code JLW

K001606 is an FDA 510(k) premarket notification submitted by Repromedix Corp. for the device "REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)". The FDA issued a decision of Substantially Equivalent on October 5, 2000. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Repromedix Corp. has at least 2 other 510(k) clearances on record.