510(k) K834219

PHASE II CORTISOL KIT by Medical & Scientific Designs, Inc. — Product Code CGR

K834219 is an FDA 510(k) premarket notification submitted by Medical & Scientific Designs, Inc. for the device "PHASE II CORTISOL KIT". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Medical & Scientific Designs, Inc. has at least 10 other 510(k) clearances on record.