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510(k) K791459

Device
AGGLUTINOTEST-LISTERIA
Applicant
VOLU SOL MEDICAL INDUSTRIES
510(k) number
K791459
Product code
GSH  
Decision
Substantially Equivalent (SESE)
Decision date
1979-09-24
Date received
1979-08-06
Regulation
866.3355
Classification name
Antisera, All Types, Listeria Monocytogenes
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

Legacy Summary#

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FDA Review#

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