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510(k) K772075

Device
RADIAL IMMUNODIFFUSION KIT-COMPLEMENT
Applicant
GELMAN INSTRUMENT CO.
510(k) number
K772075
Product code
DAY  
Decision
Substantially Equivalent (SESE)
Decision date
1978-02-03
Date received
1977-11-03
Regulation
866.5240
Classification name
Complement C5, 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 DAY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K942326HUMAN C5 RID KITSJay H. Geller1995-08-24
K950102HUMAN C-5 RADIAL IMMUNODIFFUSION KITKent Laboratories, Inc.1995-04-10

Legacy Summary#

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FDA Review#

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