SAS SHIGELLA BOYDII TYPE 12 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 Boydii Type 12 Antiserum.

Pre-market Notification Details

Device IDK961529
510k NumberK961529
Device Name:SAS SHIGELLA BOYDII TYPE 12 ANTISERUM
ClassificationAntisera, All Types, Shigella 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 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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