Accelerate Pheno System, Accelerate PhenoTest BC Kit
K-Number: K192665 · 2020-09-15
Device Summary
Frequently Asked Questions
What is the Accelerate Pheno System, Accelerate PhenoTest BC Kit?
Accelerate Pheno System, Accelerate PhenoTest BC Kit is a medical device that received FDA 510(k) clearance on 2020-09-15. The listed applicant is Accelerate Diagnostics, Inc.. The 510(k) number is K192665.
When did Accelerate Pheno System, Accelerate PhenoTest BC Kit receive FDA 510(k) clearance?
Accelerate Pheno System, Accelerate PhenoTest BC Kit received FDA 510(k) clearance on 2020-09-15, under 510(k) number K192665.
Who is the listed applicant for Accelerate Pheno System, Accelerate PhenoTest BC Kit?
The FDA 510(k) record lists Accelerate Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Accelerate Pheno System, Accelerate PhenoTest BC Kit?
The FDA product code for Accelerate Pheno System, Accelerate PhenoTest BC Kit is PRH.
Other records listing Accelerate Diagnostics, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.