510(k) K791301

ORTHO TSH RIA KIT by Ortho Diagnostics, Inc. — Product Code JLW

K791301 is an FDA 510(k) premarket notification submitted by Ortho Diagnostics, Inc. for the device "ORTHO TSH RIA KIT". The FDA issued a decision of Substantially Equivalent on September 24, 1979. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Ortho Diagnostics, Inc. has at least 10 other 510(k) clearances on record.