SAS RSV TEST

Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus

SA SCIENTIFIC, INC.

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

Pre-market Notification Details

Device IDK022845
510k NumberK022845
Device Name:SAS RSV TEST
ClassificationAntigen, Cf (including Cf Controls), Respiratory Syncytial Virus
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 CodeGQG  
CFR Regulation Number866.3480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-08-27
Decision Date2003-01-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00722066001974 K022845 000

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