510(k) K052301

FASTPACK TSH IMMUNOASSAY by Qualigen, Inc. — Product Code JLW

K052301 is an FDA 510(k) premarket notification submitted by Qualigen, Inc. for the device "FASTPACK TSH IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on January 4, 2006. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Qualigen, Inc. has at least 10 other 510(k) clearances on record.