510(k) K000874

URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 by Bio-Rad — Product Code JJW

K000874 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100". The FDA issued a decision of Substantially Equivalent on April 18, 2000. 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.