510(k) K973718

ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS by Roche Molecular Systems, Inc. — Product Code MKZ

K973718 is an FDA 510(k) premarket notification submitted by Roche Molecular Systems, Inc. for the device "ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS". The FDA issued a decision of Substantially Equivalent on December 15, 1998. The device falls under product code MKZ (Dna Probe, Nucleic Acid Amplification, Chlamydia), a Class I device regulated under 21 CFR 866.3120. Roche Molecular Systems, Inc. has at least 10 other 510(k) clearances on record.