510(k) K042446

QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS by Bio-Rad Laboratories, Inc. — Product Code JJW

K042446 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories, Inc. for the device "QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS". The FDA issued a decision of Substantially Equivalent on November 2, 2004. The device falls under product code JJW (Urinalysis Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Bio-Rad Laboratories, Inc. has at least 10 other 510(k) clearances on record.