SAS STREP A TEST

Antigens, All Groups, Streptococcus Spp.

SA SCIENTIFIC, INC.

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

Pre-market Notification Details

Device IDK993456
510k NumberK993456
Device Name:SAS STREP A TEST
ClassificationAntigens, All Groups, Streptococcus Spp.
Applicant SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio,  TX  78240
ContactHarbi A Shadfan
CorrespondentHarbi A Shadfan
SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio,  TX  78240
Product CodeGTY  
CFR Regulation Number866.3740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-13
Decision Date2000-03-07

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