APTIMA COMBO 2 ASSAY

Dna-reagents, Neisseria

GEN-PROBE, INC.

The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Aptima Combo 2 Assay.

Pre-market Notification Details

Device IDK111409
510k NumberK111409
Device Name:APTIMA COMBO 2 ASSAY
ClassificationDna-reagents, Neisseria
Applicant GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego,  CA  92121 -4362
ContactJody J Fleming
CorrespondentJody J Fleming
GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego,  CA  92121 -4362
Product CodeLSL  
Subsequent Product CodeMKZ
Subsequent Product CodeNSU
CFR Regulation Number866.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-19
Decision Date2012-05-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15420045504141 K111409 000
15420045500280 K111409 000
15420045500273 K111409 000

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