APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module
FDA 510(k) clearance K200839 · decided 2021-10-28
Clearance details
- K-number
- K200839
- Device name
- APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module
- Applicant
- Clever Culture Systems
- Decision
- Substantially Equivalent
- Date received
- 2020-03-31
- Decision date
- 2021-10-28
- Days to decision
- 576 days
- Clearance type
- Traditional
- Product code
- QQY
- Device class
- 2
- Regulation number
- 866.2190
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Bach, CH
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App (K213280) | Bd Kiestra B.V. | 2023-05-04 |
Recalls involving this device
No recalls on record reference this clearance.