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510(k) K822826

Device
ANTIBODY TO MUMPS VIRUS IFA TEST
Applicant
ELECTRO-NUCLEONICS LABORATORIES, INC.
510(k) number
K822826
Product code
GRA  
Decision
Substantially Equivalent (SESE)
Decision date
1982-12-03
Date received
1982-09-21
Regulation
866.3380
Classification name
Antiserum, Fluorescent, 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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GRA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K894624MUMPS VIRUSBion Ent., Ltd.1989-10-16
K770216VIRAL ANTISERA, FLUORESCEIN LABELEDFlow Laboratories, Inc.1977-03-01

Legacy Summary#

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FDA Review#

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