Accelerate Pheno system, Accelerate Phenotest BC Kit— 510(k) DEN160032

Name: FDA 510(k) clearance DEN160032
Creator: U.S. Food and Drug Administration
Published: 2017-02-23

Unknown

Accelerate Diagnotics

FDA 510(k) clearance DEN160032 for Accelerate Pheno system, Accelerate Phenotest BC Kit, Unknown on 2017-02-23. Applicant: Accelerate Diagnotics. Device class: 2.

Clearance details

Applicant: Accelerate Diagnotics
Product code: Code PRH
Device class: Class 2
Regulation: 21 CFR 866.1650
Advisory panel: Microbiology
Date received: 2016-07-11
Decision date: 2017-02-23
Decision: Unknown
Clearance type: Direct
Location: Tucson, AZ, US

View on FDA.gov ↗

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