PROADENO+ ASSAY

Respiratory Virus Panel Nucleic Acid Assay System

GEN-PROBE PRODESSE, INC

The following data is part of a premarket notification filed by Gen-probe Prodesse, Inc with the FDA for Proadeno+ Assay.

Pre-market Notification Details

Device IDK132159
510k NumberK132159
Device Name:PROADENO+ ASSAY
ClassificationRespiratory Virus Panel Nucleic Acid Assay System
Applicant GEN-PROBE PRODESSE, INC 20925 CROSSROADS CIRCLE Waukesha,  WI  53186
ContactEmily Ziegler
CorrespondentEmily Ziegler
GEN-PROBE PRODESSE, INC 20925 CROSSROADS CIRCLE Waukesha,  WI  53186
Product CodeOCC  
CFR Regulation Number866.3980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-12
Decision Date2013-08-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15420045506381 K132159 000

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