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510(k) K790713

Device
ANTISERUM TO HUMAN HEMOPEXIN
Applicant
KENT LABORATORIES, INC.
510(k) number
K790713
Product code
CZX  
Decision
Substantially Equivalent (SESE)
Decision date
1979-09-04
Date received
1979-04-12
Regulation
866.5490
Classification name
Hemopexin, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CZX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K801432HEMOPEXIN NEPHELOMETRIC ASSAYJ.T. Baker Chemical Co.1980-07-08
K780250HEMOPEXIN NEPHELOMETRIC ASSAYSKallestad Laboratories, Inc.1978-02-28

Legacy Summary#

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FDA Review#

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