SAS SALMONELLA H D ANTIGEN

Antigens (febrile), Agglutination, Brucella Spp.

SA SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Salmonella H D Antigen.

Pre-market Notification Details

Device IDK952135
510k NumberK952135
Device Name:SAS SALMONELLA H D ANTIGEN
ClassificationAntigens (febrile), Agglutination, Brucella Spp.
Applicant SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio,  TX  78240
ContactHarbi Shadfan
CorrespondentHarbi Shadfan
SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio,  TX  78240
Product CodeGSO  
CFR Regulation Number866.3085 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-08
Decision Date1995-07-17

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