510(k) K010734

BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21 by Branan Medical Corp. — Product Code MLK

K010734 is an FDA 510(k) premarket notification submitted by Branan Medical Corp. for the device "BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21". The FDA issued a decision of Substantially Equivalent on July 30, 2001. The device falls under product code MLK (Thin Layer Chromatography, Tricyclic Antidepressant Drugs), a Class II device regulated under 21 CFR 862.3910. Branan Medical Corp. has at least 10 other 510(k) clearances on record.