510(k) K183462
K183462 is an FDA 510(k) premarket notification submitted by Mriglobal for the device "Applied Biosystems Bacillus anthracis Detection Kit". The FDA issued a decision of Substantially Equivalent on Oct 1, 2019.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 1, 2019
- Date Received
- Dec 14, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No