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510(k) K802933

Device
MUMPS S & V ANTIGENS & CONTROLS
Applicant
ORION DIAGNOSTICA, INC.
510(k) number
K802933
Product code
GRC  
Decision
Substantially Equivalent (SESE)
Decision date
1980-12-31
Date received
1980-11-19
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#

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 GRC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K905306MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGENVirion (U.S.), Inc.1991-06-17
K832873MUMPS COMPLEMENT FIXATION & HEMAGGLUHazleton Dutchland, Inc.1983-12-27

Legacy Summary#

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FDA Review#

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