GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088

Dna Probe, Nucleic Acid Amplification, Chlamydia

GEN-PROBE, INC.

The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Gen-probe Aptima Assay For Chlamydia Trachomatis, Model 1088.

Pre-market Notification Details

Device IDK053446
510k NumberK053446
Device Name:GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088
ClassificationDna Probe, Nucleic Acid Amplification, Chlamydia
Applicant GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego,  CA  92121 -4362
ContactBrian J Shea
CorrespondentBrian J Shea
GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego,  CA  92121 -4362
Product CodeMKZ  
CFR Regulation Number866.3120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-12
Decision Date2006-07-25
Summary:summary

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