58 results
424B1
AXDX
Accelerate Diagnostics Inc
22 Jan 24
Prospectus with pricing info
9:59pm
devices, or devices that otherwise present a potential unreasonable risk of illness or injury. However, some devices are automatically classified … product for those important or commercially attractive uses that were not cleared, approved, or de novo classified.
On October 21, 2022, the Company
S-1/A
AXDX
Accelerate Diagnostics Inc
16 Jan 24
IPO registration (amended)
7:18am
are automatically classified as Class III and subject to the PMA pathway regardless of the level of risk they pose, because there is no legally marketed … not be permitted to market our product for those important or commercially attractive uses that were not cleared, approved, or de novo classified.
On October 21
S-1
AXDX
Accelerate Diagnostics Inc
13 Dec 23
IPO registration
5:30pm
unreasonable risk of illness or injury. However, some devices are automatically classified as Class III and subject to the PMA pathway regardless of the level … not cleared, approved, or de novo classified.
On October 21, 2022, the Company announced it has been in recent discussions with the FDA regarding