ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY

Assay, Erythropoietin

NICHOLS INSTITUTE DIAGNOSTICS

The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Advantage Chemiluminescence Erythropoietin Immunoassay.

Pre-market Notification Details

Device IDK980737
510k NumberK980737
Device Name:ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY
ClassificationAssay, Erythropoietin
Applicant NICHOLS INSTITUTE DIAGNOSTICS 33051 CALLE AVIADOR San Juan Capistrano,  CA  92675
ContactJimmy Wong
CorrespondentJimmy Wong
NICHOLS INSTITUTE DIAGNOSTICS 33051 CALLE AVIADOR San Juan Capistrano,  CA  92675
Product CodeGGT  
CFR Regulation Number864.7250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-25
Decision Date1999-03-23
Summary:summary

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