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FDA 510(k) Applications for Medical Device Product Code "PRH"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K192665
Accelerate Diagnostics, Inc.
Accelerate Pheno System, Accelerate PhenoTest BC Kit
09/15/2020
DEN160032
ACCELERATE DIAGNOTICS
Accelerate Pheno system, Accelerate Phenotest BC Kit
02/23/2017
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