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510(k) K844407

Device
DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K844407
Product code
GTJ  
Decision
Substantially Equivalent (SESE)
Decision date
1985-01-25
Date received
1984-11-13
Regulation
866.3390
Classification name
Antisera, All Groups, N. Meningitidis
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RUSSELL J ARNSBERGE
Address
1875 Eye St. NW Suite 625 Washington DC US 20006 20006

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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