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510(k) K942326

Device
HUMAN C5 RID KITS
Applicant
JAY H. GELLER
510(k) number
K942326
Product code
DAY  
Decision
Substantially Equivalent (SESE)
Decision date
1995-08-24
Date received
1994-05-13
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
JAY H GELLER
Address
2425 W. Olympic Blvd. Suite 600 Santa Monica CA US 90404 90404

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
K950102HUMAN C-5 RADIAL IMMUNODIFFUSION KITKent Laboratories, Inc.1995-04-10
K772075RADIAL IMMUNODIFFUSION KIT-COMPLEMENTGelman Instrument Co.1978-02-03

Legacy Summary#

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FDA Review#

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