Visby Medical Sexual Health

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

Visby Medical

The following data is part of a premarket notification filed by Visby Medical with the FDA for Visby Medical Sexual Health.

Pre-market Notification Details

Device IDK200748
510k NumberK200748
Device Name:Visby Medical Sexual Health
ClassificationNucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Applicant Visby Medical 3010 N. First Street San Jose,  CA  95134
ContactCarolyn Glickman
CorrespondentBeth Lingenfelter
Visby Medical 3010 North First Street San Jose,  CA  95134
Product CodeQEP  
Subsequent Product CodeLSL
Subsequent Product CodeMKZ
Subsequent Product CodeOUY
CFR Regulation Number866.3393 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeDual Track
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-23
Decision Date2021-08-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810031720057 K200748 000
00810031720033 K200748 000
00810031720002 K200748 000

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