510(k) K923532

NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY by Solarcare Technologies Corp,Inc. — Product Code JLW

K923532 is an FDA 510(k) premarket notification submitted by Solarcare Technologies Corp,Inc. for the device "NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY". The FDA issued a decision of Substantially Equivalent on March 12, 1993. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Solarcare Technologies Corp,Inc. has at least 10 other 510(k) clearances on record.