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510(k) K882822

Device
FIAGEN FERRITIN
Applicant
CYBERFLUOR, INC.
510(k) number
K882822
Product code
DFL  
Decision
Substantially Equivalent (SESE)
Decision date
1988-08-04
Date received
1988-07-08
Regulation
866.5550
Classification name
Igm, Ferritin, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES CLELLAND
Address
179 John St., 4th Floor , Toronto Ontario M5t 1x4 CA

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DFL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K883493TECHNICON DPA-1 IMMUNOGLOBULIN MTechnicon Instruments Corp.1988-09-22
K772079RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.MGelman Instrument Co.1978-02-03

Legacy Summary#

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FDA Review#

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