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510(k) K894624

Device
MUMPS VIRUS
Applicant
BION ENT., LTD.
510(k) number
K894624
Product code
GRA  
Decision
Substantially Equivalent (SESE)
Decision date
1989-10-16
Date received
1989-07-20
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#

Contact
JUDY MCCORMACK
Address
674 Busse Hwy. Park Ridge IL US 60068 60068

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
K822826ANTIBODY TO MUMPS VIRUS IFA TESTElectro-Nucleonics Laboratories, Inc.1982-12-03
K770216VIRAL ANTISERA, FLUORESCEIN LABELEDFlow Laboratories, Inc.1977-03-01

Legacy Summary#

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FDA Review#

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