510(k) K052053

LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK by Bio-Rad — Product Code DIF

K052053 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK". The FDA issued a decision of Substantially Equivalent on August 9, 2005. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Bio-Rad has at least 10 other 510(k) clearances on record.