510(k) K930006

AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT by Bio-Chem Laboratory Systems, Inc. — Product Code JLW

K930006 is an FDA 510(k) premarket notification submitted by Bio-Chem Laboratory Systems, Inc. for the device "AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT". The FDA issued a decision of Substantially Equivalent on September 9, 1993. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Bio-Chem Laboratory Systems, Inc. has at least 4 other 510(k) clearances on record.