SAS SALMONELLA E,N,X ANTISERUM

Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.

SA SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Salmonella E,n,x Antiserum.

Pre-market Notification Details

Device IDK955214
510k NumberK955214
Device Name:SAS SALMONELLA E,N,X ANTISERUM
ClassificationAntigens, Febrile, Slide And Tube, All Groups, Salmonella 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 CodeGNC  
CFR Regulation Number866.3550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-14
Decision Date1996-02-07

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