Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)

Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections

Hologic, Inc.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Aptima Combo 2 Assay (panther System), Aptima Combo 2 Assay (tigris) System).

Pre-market Notification Details

Device IDK200866
510k NumberK200866
Device Name:Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
ClassificationNucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Applicant Hologic, Inc. 10210 Genetic Center Drive San Diego,  CA  92121
ContactAnila Tarte
CorrespondentAnila Tarte
Hologic, Inc. 10210 Genetic Center Drive San Diego,  CA  92121
Product CodeQEP  
Subsequent Product CodeLSL
Subsequent Product CodeMKZ
CFR Regulation Number866.3393 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-01
Decision Date2020-05-17

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