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510(k) K791397

Device
HERPES EIA TEST KIT
Applicant
MICROBIOLOGICAL ASSOC.
510(k) number
K791397
Product code
GQM  
Decision
Substantially Equivalent (SESE)
Decision date
1979-09-24
Date received
1979-07-27
Regulation
866.3305
Classification name
Antisera, Neutralization, Herpesvirus Hominis
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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GQM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K875367COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMVEnzo Biochem, Inc.1988-03-28
K810043GOAT ANTI-HERPES SIMPLEX VIRUS TYPE IVibac Corp.1981-05-15

Legacy Summary#

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FDA Review#

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