510(k) K962464

SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY) by Scantibodies Laboratory, Inc. — Product Code JLW

K962464 is an FDA 510(k) premarket notification submitted by Scantibodies Laboratory, Inc. for the device "SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY)". The FDA issued a decision of Substantially Equivalent on October 8, 1996. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Scantibodies Laboratory, Inc. has at least 10 other 510(k) clearances on record.