SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM

Antisera, All Types, Shigella Spp.

SA SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Shigella Flexneri Type 5 Antiserum.

Pre-market Notification Details

Device IDK961532
510k NumberK961532
Device Name:SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM
ClassificationAntisera, All Types, Shigella Spp.
Applicant SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio,  TX  78240
ContactMartin P O'connor
CorrespondentMartin P O'connor
SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio,  TX  78240
Product CodeGNB  
CFR Regulation Number866.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-22
Decision Date1996-05-20

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