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510(k) K875367

Device
COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV
Applicant
ENZO BIOCHEM, INC.
510(k) number
K875367
Product code
GQM  
Decision
Substantially Equivalent (SESE)
Decision date
1988-03-28
Date received
1987-12-31
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#

Contact
PAULA OLSIEWSKI
Address
325 Hudson St. New York NY US 10013 10013

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
K810043GOAT ANTI-HERPES SIMPLEX VIRUS TYPE IVibac Corp.1981-05-15
K791397HERPES EIA TEST KITMicrobiological Assoc.1979-09-24

Legacy Summary#

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FDA Review#

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