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FDA 510(k), K192665, Accelerate Pheno System, Accelerate PhenoTest BC Kit
FDA 510(k), K192665, Accelerate Pheno System, Accelerate PhenoTest BC Kit
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$89.00 USD
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510(K) Number: K192665
Device Name: Accelerate Pheno System, Accelerate PhenoTest BC Kit
Manufacturer: Accelerate Diagnostics, Inc.
Device Classification Name: Positive Blood Culture Identification And Ast Kit
Regulation Number:
Classification Product Code: PRH
Date Received: 09/25/2019
Decision Date: 09/15/2020
Regulation Medical Specialty: Microbiology
Device Name: Accelerate Pheno System, Accelerate PhenoTest BC Kit
Manufacturer: Accelerate Diagnostics, Inc.
Device Classification Name: Positive Blood Culture Identification And Ast Kit
Regulation Number:
Classification Product Code: PRH
Date Received: 09/25/2019
Decision Date: 09/15/2020
Regulation Medical Specialty: Microbiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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