510(k) K820341

CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT by E. R. Squibb & Sons, Inc. — Product Code CGR

K820341 is an FDA 510(k) premarket notification submitted by E. R. Squibb & Sons, Inc. for the device "CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on March 4, 1982. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. E. R. Squibb & Sons, Inc. has at least 10 other 510(k) clearances on record.