FDA.reportPublic FDA data

510(k) K953320

Device
Sas Shigella Dysenteriae Type 4 Antiserum
Applicant
SA SCIENTIFIC, INC.
510(k) number
K953320
Product code
GNB
Decision
Substantially Equivalent (SESE)
Decision date
1995-08-04
Date received
1995-07-13
Regulation
866.3660
Classification name
Antisera, All Types, Shigella Spp.
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
HARBI SHADFAN
Address
4919 Golden Quail San Antonio TX US 78240 78240

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GNB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K961537SAS SHIGELLA SONNEI FORM II ANTISERUMSa Scientific, Inc.1996-05-31
K961546SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUMSa Scientific, Inc.1996-05-20
K961533SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUMSa Scientific, Inc.1996-05-20
K961534SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML)Sa Scientific, Inc.1996-05-20
K961535SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUMSa Scientific, Inc.1996-05-20
K961538SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUMSa Scientific, Inc.1996-05-20
K961539SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUMSa Scientific, Inc.1996-05-20
K961540SAS SHIGELLA SONNEI GROUP D ANTISERUMSa Scientific, Inc.1996-05-20
K961541SAS SHIGELLA BOYDII TYPE 8 ANTISERUMSa Scientific, Inc.1996-05-20
K961542SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUMSa Scientific, Inc.1996-05-20
K961543SAS SHIGELLA BOYDII TYPE 9 ANTISERUMSa Scientific, Inc.1996-05-20
K961532SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUMSa Scientific, Inc.1996-05-20
K961547SAS SHIGELLA BOYDII TYPE 14 ANTISERUMSa Scientific, Inc.1996-05-20
K961548SAS SHIGELLA BOYDII TYPE 15 ANTISERUMSa Scientific, Inc.1996-05-20
K961549SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUMSa Scientific, Inc.1996-05-20