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510(k) K883493

Device
TECHNICON DPA-1 IMMUNOGLOBULIN M
Applicant
TECHNICON INSTRUMENTS CORP.
510(k) number
K883493
Product code
DFL  
Decision
Substantially Equivalent (SESE)
Decision date
1988-09-22
Date received
1988-08-16
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
LEONARD A DWARICA
Address
511 Benedict Ave. Tarrytown NY US 10591 10591

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
K882822FIAGEN FERRITINCyberfluor, Inc.1988-08-04
K772079RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.MGelman Instrument Co.1978-02-03

Legacy Summary#

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FDA Review#

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