510(k) K213280
K213280 is an FDA 510(k) premarket notification submitted by Bd Kiestra B.V. for the device "BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App". The FDA issued a decision of Substantially Equivalent on May 4, 2023. The device falls under product code QQY (Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms), a Class II device regulated under 21 CFR 866.2190.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2023
- Date Received
- October 1, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
- Device Class
- Class II
- Regulation Number
- 866.2190
- Review Panel
- MI
- Submission Type
Culture plate imaging system for qualitative assessment of resistant organisms is an automated system to assess the presence or absence of colony growth on solid chromogenic culture media.