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510(k) K791385

Device
NEGATIVE CONTROL SERUM FOR CF RO ID
Applicant
IMMUNO-MYCOLOGICS, INC.
510(k) number
K791385
Product code
GSN  
Decision
Substantially Equivalent (SESE)
Decision date
1979-08-16
Date received
1979-07-11
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
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 GSN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K952145SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUMSa Scientific, Inc.1995-07-18
K885113IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROLInvestigacion Farmaceutica S.A. DE C.V.1989-08-15

Legacy Summary#

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FDA Review#

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