SAS INFLUENZA A 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 Test.

Pre-market Notification Details

Device IDK041441
510k NumberK041441
Device Name:SAS INFLUENZA A TEST
ClassificationDevices Detecting Influenza A, B, And C Virus Antigens
Applicant SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio,  TX  78240
ContactRicardo R Martinez
CorrespondentRicardo R Martinez
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 Received2004-06-01
Decision Date2004-07-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00722066003343 K041441 000

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