SAS SALMONELLA 0 GROUP M FACTOR 28 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 0 Group M Factor 28 Antiserum.

Pre-market Notification Details

Device IDK960160
510k NumberK960160
Device Name:SAS SALMONELLA 0 GROUP M FACTOR 28 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 Received1996-01-11
Decision Date1996-03-12

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