510(k) K931227

USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 by U.S. Drug Testing, Inc. — Product Code KZR

K931227 is an FDA 510(k) premarket notification submitted by U.S. Drug Testing, Inc. for the device "USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000". The FDA issued a decision of Substantially Equivalent on May 6, 1993. The device falls under product code KZR (Chromatography (Liquid, Gel), Clinical Use), a Class I device regulated under 21 CFR 862.2260. U.S. Drug Testing, Inc. has at least 5 other 510(k) clearances on record.