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510(k) K882622

Device
CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM
Applicant
TECHNICON INSTRUMENTS CORP.
510(k) number
K882622
Product code
JFR  
Decision
Substantially Equivalent (SESE)
Decision date
1988-07-08
Date received
1988-06-24
Regulation
866.5210
Classification name
Indirect Copper Assay, Ceruloplasmin
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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JFR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K051456SENTINEL CERULOPLASMINSentinel Ch. Srl2005-10-21

Legacy Summary#

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FDA Review#

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