510(k) K002272

BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D by Branan Medical Corp. — Product Code LCM

K002272 is an FDA 510(k) premarket notification submitted by Branan Medical Corp. for the device "BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D". The FDA issued a decision of Substantially Equivalent on November 22, 2000. The device falls under product code LCM (Enzyme Immunoassay, Phencyclidine), a Class U device. Branan Medical Corp. has at least 10 other 510(k) clearances on record.