510(k) K991146

TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 by Biocheck, Inc. — Product Code JLW

K991146 is an FDA 510(k) premarket notification submitted by Biocheck, Inc. for the device "TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001". The FDA issued a decision of Substantially Equivalent on June 22, 1999. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Biocheck, Inc. has at least 10 other 510(k) clearances on record.