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510(k) K952145

Device
Sas Febrile Positive & Negative Control Antiserum
Applicant
SA SCIENTIFIC, INC.
510(k) number
K952145
Product code
GSN
Decision
Substantially Equivalent (SESE)
Decision date
1995-07-18
Date received
1995-05-08
Regulation
866.3085
Classification name
Antiserum, Positive And Negative Febrile Antigen Control Serum
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 GSN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K885113IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROLInvestigacion Farmaceutica S.A. DE C.V.1989-08-15
K791385NEGATIVE CONTROL SERUM FOR CF RO IDImmuno-Mycologics, Inc.1979-08-16