SAS SALMONELLA O POLY B ANTISERUM

Antisera, 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 O Poly B Antiserum.

Pre-market Notification Details

Device IDK961967
510k NumberK961967
Device Name:SAS SALMONELLA O POLY B ANTISERUM
ClassificationAntisera, 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 CodeGRM  
CFR Regulation Number866.3550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-20
Decision Date1996-06-18

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