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510(k) K946266

Device
FERRITIN CONTROL - LEVEL 1, 2, 3
Applicant
CLINICAL CONTROLS, INC.
510(k) number
K946266
Product code
DGD  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-10
Date received
1994-12-23
Regulation
866.5510
Classification name
Igg, Ferritin, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JAMES F GODFREY
Address
750 Farroll Rd. Suite B Grover Beach CA US 93433 93433

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DGD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881345IMX FERRITINAbbott Laboratories1988-05-11
K830229ROENTGENOGRAPHY SETMallinckrodt Critical Care1983-03-09

Legacy Summary#

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FDA Review#

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