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510(k) K952132

Device
SAS BRUCELLA AMS ANTISERUM
Applicant
SA SCIENTIFIC, INC.
510(k) number
K952132
Product code
GSM  
Decision
Substantially Equivalent (SESE)
Decision date
1995-07-21
Date received
1995-05-08
Regulation
866.3085
Classification name
Antisera, Fluorescent, Brucella Spp.
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
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 GSM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K952143SAS BRUCELLA MELITENSIS ANTISERUMSa Scientific, Inc.1995-07-21
K952144SAS BRUCELLA SUIS ANTISERUMSa Scientific, Inc.1995-07-21
K952146SAS BRUCELLAS ABORTUS ANTISERUMSa Scientific, Inc.1995-07-21

Legacy Summary#

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FDA Review#

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