510(k) K870500

MAJOR QUALITY GLUCOSE AND KETONES URINE TEST by American Diagnostic Corp. — Product Code JIL

K870500 is an FDA 510(k) premarket notification submitted by American Diagnostic Corp. for the device "MAJOR QUALITY GLUCOSE AND KETONES URINE TEST". The FDA issued a decision of Substantially Equivalent on March 6, 1987. The device falls under product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. American Diagnostic Corp. has at least 10 other 510(k) clearances on record.