B. Anthracis Real-time PCR Assay

Assay, Nucleic Acid Amplification, Bacillus Anthracis

Centers For Disease Control And Prevention

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

Pre-market Notification Details

Device IDK192871
510k NumberK192871
Device Name:B. Anthracis Real-time PCR Assay
ClassificationAssay, Nucleic Acid Amplification, Bacillus Anthracis
Applicant Centers For Disease Control And Prevention 1600 Clifton Road NE, MS: H24-11 Atlanta,  GA  30329
ContactYon Yu
CorrespondentJulie Villanueva
Centers For Disease Control And Prevention 1600 Clifton Road NE, MS: H24-11 Atlanta,  GA  30329
Product CodeNHT  
CFR Regulation Number866.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-08
Decision Date2019-11-07
Summary:summary

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