Rickettsia Real-time PCR Assay

Rickettsia Spp. Nucleic Acid Based Detection Assay

Centers For Disease Control And Prevention (CDC)

The following data is part of a premarket notification filed by Centers For Disease Control And Prevention (cdc) with the FDA for Rickettsia Real-time Pcr Assay.

Pre-market Notification Details

Device IDK170940
510k NumberK170940
Device Name:Rickettsia Real-time PCR Assay
ClassificationRickettsia Spp. Nucleic Acid Based Detection Assay
Applicant Centers For Disease Control And Prevention (CDC) 1600 Clifton Road MS-C18 Atlanta,  GA  30329
ContactYon Yu
CorrespondentYon Yu
Centers For Disease Control And Prevention (CDC) 1600 Clifton Road MS-C18 Atlanta,  GA  30329
Product CodePVQ  
CFR Regulation Number866.3316 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-30
Decision Date2017-06-29

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