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510(k) K885110

Device
PROTEUS OX-19 IFA*
Applicant
INVESTIGACION FARMACEUTICA S.A. DE C.V.
510(k) number
K885110
Product code
GSZ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-08-15
Date received
1988-12-12
Regulation
866.3410
Classification name
Antigens, Febrile (weil-felix), All Groups
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SMITHERS HOGG.
Address
Calle 13-E # 5 Civac Jiutepec, Morelos Mexico MX

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GSZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K760881FEBRILE ANTIGEN CONTROL SERABd Becton Dickinson Vacutainer Systems Preanalytic1976-11-09
K760097FEBRILE ANTIGENS & CONTROL SERUMSGamma Biologicals, Inc.1976-08-03

Legacy Summary#

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FDA Review#

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