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510(k) K760097

Device
FEBRILE ANTIGENS & CONTROL SERUMS
Applicant
GAMMA BIOLOGICALS, INC.
510(k) number
K760097
Product code
GSZ  
Decision
Substantially Equivalent (SESE)
Decision date
1976-08-03
Date received
1976-06-14
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#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K885110PROTEUS OX-19 IFA*Investigacion Farmaceutica S.A. DE C.V.1989-08-15
K760881FEBRILE ANTIGEN CONTROL SERABd Becton Dickinson Vacutainer Systems Preanalytic1976-11-09

Legacy Summary#

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FDA Review#

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