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510(k) K950102

Device
HUMAN C-5 RADIAL IMMUNODIFFUSION KIT
Applicant
KENT LABORATORIES, INC.
510(k) number
K950102
Product code
DAY  
Decision
Substantially Equivalent (SESE)
Decision date
1995-04-10
Date received
1995-01-11
Regulation
866.5240
Classification name
Complement C5, 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
DONALD A JORGENSEN
Address
23404 NE 8th St. Redmond WA US 98053 98053

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DAY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K942326HUMAN C5 RID KITSJay H. Geller1995-08-24
K772075RADIAL IMMUNODIFFUSION KIT-COMPLEMENTGelman Instrument Co.1978-02-03

Legacy Summary#

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FDA Review#

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