Accelerate Diagnostics Inc

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Known Names

accelerate diagnostics, accelerate diagnostics inc

Recent Recalls

NumberClassProductDate
Z-0345-2023Class IIAccelerate PhenoTest BC kit REF 10101018October 17, 2022
Z-0346-2023Class IIAccelerate PhenoTest BC kit REF 10102018October 17, 2022
Z-1529-2018Class IIAccelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, TMarch 14, 2018
Z-1065-2019Class IIAccelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product March 13, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K240854Accelerate Arc SystemSeptember 26, 2024
K192665Accelerate Pheno System, Accelerate PhenoTest BC KitSeptember 15, 2020