FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module
K Number: K200839
·
Decision Oct 28, 2021
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
1
Applicant Total
1
Review Days
576
Basic Information
- Device Name
- APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module
- K Number
- K200839
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.2190
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clever Culture Systems
- Date Received
- March 31, 2020
- Decision Date
- October 28, 2021
- Product Code
- QQY
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QQY | Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QQY), ordered by most recent decision date.
View all