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510(k) K832260

Device
GOAT ANTI-HUMAN KAPPA AFFINITY
Applicant
GELCO DIAGNOSTICS, INC.
510(k) number
K832260
Product code
DEO  
Decision
Substantially Equivalent (SESE)
Decision date
1983-10-31
Date received
1983-06-30
Regulation
866.5550
Classification name
Kappa, Fitc, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DEO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K831904RABBIT ANTISERUM TO HUMAN KAPPA LIGHTDako Corp.1983-07-19

Legacy Summary#

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FDA Review#

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