FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor A, Clone EPI, RTU (Dako Onmis)

Immunohistochemistry Antibody Assay, Estrogen Receptor

DAKO DENMARK A/S

The following data is part of a premarket notification filed by Dako Denmark A/s with the FDA for Flex Monoclonal Rabbit Anti-human Estrogen Receptor A, Clone Epi, Rtu (dako Onmis).

Pre-market Notification Details

Device IDK170028
510k NumberK170028
Device Name:FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor A, Clone EPI, RTU (Dako Onmis)
ClassificationImmunohistochemistry Antibody Assay, Estrogen Receptor
Applicant DAKO DENMARK A/S PRODUKTIONSVEJ 42 Glostrup,  DK 2600
ContactLasse Post Moller
CorrespondentLasse Post Moller
DAKO DENMARK A/S PRODUKTIONSVEJ 42 Glostrup,  DK 2600
Product CodeMYA  
CFR Regulation Number864.1860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-03
Decision Date2017-12-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05700571108147 K170028 000

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