510(k) K832710

VITAMIN B12 RADIOASSAY KIT CA-1534 by Clinical Assays, Inc. — Product Code CDD

K832710 is an FDA 510(k) premarket notification submitted by Clinical Assays, Inc. for the device "VITAMIN B12 RADIOASSAY KIT CA-1534". The FDA issued a decision of Substantially Equivalent on October 4, 1983. The device falls under product code CDD (Radioassay, Vitamin B12), a Class II device regulated under 21 CFR 862.1810. Clinical Assays, Inc. has at least 10 other 510(k) clearances on record.