ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST

Dna Probe, Nucleic Acid Amplification, Chlamydia

ROCHE MOLECULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Roche Cobas Amplicor Chlamydia Trachomatis Test.

Pre-market Notification Details

Device IDK964507
510k NumberK964507
Device Name:ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST
ClassificationDna Probe, Nucleic Acid Amplification, Chlamydia
Applicant ROCHE MOLECULAR SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3711
ContactAlex Wesolowski
CorrespondentAlex Wesolowski
ROCHE MOLECULAR SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3711
Product CodeMKZ  
CFR Regulation Number866.3120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-08
Decision Date1997-06-13
Summary:summary

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