ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH

Radioimmunoassay, 17-hydroxyprogesterone

NEO-GENESIS

The following data is part of a premarket notification filed by Neo-genesis with the FDA for Accuwell 17-alpha-hydroxyproesterone Enzyme Immunoassay With Models 6015xx-ecah.

Pre-market Notification Details

Device IDK060452
510k NumberK060452
Device Name:ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
ClassificationRadioimmunoassay, 17-hydroxyprogesterone
Applicant NEO-GENESIS 4814 N.E. 107TH AVENUE Portland,  OR  97220
ContactJannet Baldwin
CorrespondentJannet Baldwin
NEO-GENESIS 4814 N.E. 107TH AVENUE Portland,  OR  97220
Product CodeJLX  
CFR Regulation Number862.1395 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-21
Decision Date2007-03-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00725609000625 K060452 000

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