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510(k) K905306

Device
MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN
Applicant
VIRION (U.S.), INC.
510(k) number
K905306
Product code
GRC  
Decision
Substantially Equivalent (SESE)
Decision date
1991-06-17
Date received
1990-11-28
Regulation
866.3380
Classification name
Antigen, Cf (including Cf Control), Mumps Virus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
HAUSLER, JR.
Address
4 Upperfield Rd. Morristown NJ US 07960 07960

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GRC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K832873MUMPS COMPLEMENT FIXATION & HEMAGGLUHazleton Dutchland, Inc.1983-12-27
K802933MUMPS S & V ANTIGENS & CONTROLSOrion Diagnostica, Inc.1980-12-31

Legacy Summary#

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FDA Review#

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