SAS INFLUENZA A & B TEST

Devices Detecting Influenza A, B, And C Virus Antigens

SA SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Influenza A & B Test.

Pre-market Notification Details

Device IDK080380
510k NumberK080380
Device Name:SAS INFLUENZA A & B TEST
ClassificationDevices Detecting Influenza A, B, And C Virus Antigens
Applicant SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio,  TX  78240
ContactRobbi Perry
CorrespondentRobbi Perry
SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio,  TX  78240
Product CodePSZ  
CFR Regulation Number866.3328 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-13
Decision Date2009-07-23
Summary:summary

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