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510(k) K992188

Device
NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028
Applicant
NICHOLS INSTITUTE DIAGNOSTICS
510(k) number
K992188
Product code
JNM  
Decision
Substantially Equivalent (SESE)
Decision date
1999-12-06
Date received
1999-06-29
Regulation
866.5880
Classification name
Immunochemical, Transferrin
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JAMES A RYBSKI
Address
33051 Calle Aviador San Juan Capistrano CA US 92675 92675

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JNM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K981208TFRRamco Laboratories, Inc.1998-10-21
K970718QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)R&D Systems, Inc.1997-05-27

Legacy Summary#

summary

FDA Review#

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