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510(k) K915650

Device
HUMAN IGG SUBCLASS RID KIT
Applicant
JANSSEN BIOCHIMICA
510(k) number
K915650
Product code
CGM  
Decision
Substantially Equivalent (SESE)
Decision date
1992-03-26
Date received
1991-12-18
Regulation
866.5510
Classification name
Method, Immunodiffusion, Immunoglobulins (g, A, M)
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RUTH WASSERMAN
Address
40 Kingsbridge Rd. Piscataway NJ US 08855 08855

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CGM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K920006IL TEST IMMUNOGLOBULIN G (IGG)Instrumentation Laboratory CO1992-03-13
K920008IL TEST IMMUNOGLOBULIN M (IGM)Instrumentation Laboratory CO1992-03-11
K920370ISOTYPES HUMAN IGG SUBCLASS EIA KITIsotypes, Inc.1992-03-11

Legacy Summary#

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FDA Review#

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