510(k) K910837

SRI TSH IMMUNENZYMETRIC ASSAY by Serono-Baker Diagnostics, Inc. — Product Code JLW

K910837 is an FDA 510(k) premarket notification submitted by Serono-Baker Diagnostics, Inc. for the device "SRI TSH IMMUNENZYMETRIC ASSAY". The FDA issued a decision of Substantially Equivalent on May 24, 1991. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Serono-Baker Diagnostics, Inc. has at least 10 other 510(k) clearances on record.