510(k) K101390

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

K101390 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 August 13, 2010. 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.