510(k) K070174

AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY by Roche Diagnostics Corporation — Product Code MKZ

K070174 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corporation for the device "AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY". The FDA issued a decision of Substantially Equivalent on April 16, 2007. The device falls under product code MKZ (Dna Probe, Nucleic Acid Amplification, Chlamydia), a Class I device regulated under 21 CFR 866.3120. Roche Diagnostics Corporation has at least 5 other 510(k) clearances on record.