510(k) K040008

QUICKVUE ADVANCE PH AND AMINES GLL TEST by Quidel Corp. — Product Code CEN

K040008 is an FDA 510(k) premarket notification submitted by Quidel Corp. for the device "QUICKVUE ADVANCE PH AND AMINES GLL TEST". The FDA issued a decision of Substantially Equivalent on April 29, 2004. The device falls under product code CEN (Dye-Indicator, Ph (Urinary, Non-Quantitative)), a Class I device regulated under 21 CFR 862.1550. Quidel Corp. has at least 10 other 510(k) clearances on record.