510(k) K960888

CHEK-STIX U.T.I. SELF-TEST by Bayer Corp. — Product Code JMT

K960888 is an FDA 510(k) premarket notification submitted by Bayer Corp. for the device "CHEK-STIX U.T.I. SELF-TEST". The FDA issued a decision of Substantially Equivalent on July 5, 1996. The device falls under product code JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)), a Class I device regulated under 21 CFR 862.1510. Bayer Corp. has at least 10 other 510(k) clearances on record.