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Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cance — Dako Denmark A/S (PMA P100024)

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cance — Dako Denmark A/S (PMA P100024) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cance; Applicant: Dako

Device nameChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cance
ApplicantDako Denmark A/S
Clearance trackPMA
Submission numberP100024
DecisionOK30
Decision date2015-09-10
Date received2015-08-13
Product codeNYQ
Device class3
Medical specialtyUnknown
Applicant locationUS
SourceopenFDA device

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