510(k) K031231

LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS by Bio-Rad — Product Code JJW

K031231 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS". The FDA issued a decision of Substantially Equivalent on June 18, 2003. The device falls under product code JJW (Urinalysis Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Bio-Rad has at least 10 other 510(k) clearances on record.