510(k) K200839
K200839 is an FDA 510(k) premarket notification submitted by Clever Culture Systems for the device "APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module". The FDA issued a decision of Substantially Equivalent on October 28, 2021. 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. Clever Culture Systems has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 2021
- Date Received
- March 31, 2020
- 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.