510(k) K072721

LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC by Bio-Rad, Diagnostics Grp. — Product Code DIF

K072721 is an FDA 510(k) premarket notification submitted by Bio-Rad, Diagnostics Grp. for the device "LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC". The FDA issued a decision of Substantially Equivalent on December 11, 2007. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Bio-Rad, Diagnostics Grp. has at least 5 other 510(k) clearances on record.