510(k) K121143

LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) by Bio-Rad Laboratories — Product Code DIF

K121143 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories for the device "LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)". The FDA issued a decision of Substantially Equivalent on May 18, 2012. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Bio-Rad Laboratories has at least 10 other 510(k) clearances on record.