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Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement — Abbott Molecular, Inc. (PMA P110012)

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement — Abbott Molecular, Inc. (PMA P110012) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement; Applicant: Abbott Molecul

Device nameFluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
ApplicantAbbott Molecular, Inc.
Clearance trackPMA
Submission numberP110012
DecisionAPPR
Decision date2020-05-22
Date received2019-12-23
Product codeOWE
Device class3
Medical specialtyUnknown
Applicant locationIL
SourceopenFDA device

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