510(k) K972772

ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING by Trek Diagnostic Systems, Inc. — Product Code MJA

K972772 is an FDA 510(k) premarket notification submitted by Trek Diagnostic Systems, Inc. for the device "ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING". The FDA issued a decision of Substantially Equivalent on July 13, 1999. The device falls under product code MJA (Susceptibility Test Powders, Antimycobacterial), a Class II device regulated under 21 CFR 866.1640. Trek Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.