510(k) K832499

PHASE II TSH KIT by Medical & Scientific Designs, Inc. — Product Code JLW

K832499 is an FDA 510(k) premarket notification submitted by Medical & Scientific Designs, Inc. for the device "PHASE II TSH KIT". The FDA issued a decision of Substantially Equivalent on September 12, 1983. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Medical & Scientific Designs, Inc. has at least 10 other 510(k) clearances on record.